Healthdyne, Inc.
Mchenry, IL, US
Healthdyne, Inc. appears in FDA device records in Mchenry, IL. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for Healthdyne, Inc. between 1978 and 1995. The busiest year on record is 1984, with 6. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 5 |
| 1984 | 6 |
| 1985 | 1 |
| 1986 | 3 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) | BZD | Substantially Equivalent | |
| K922106 | ALICE | OLV | Substantially Equivalent | |
| K942357 | H-500 ALLIANCE OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | |
| K934502 | FLOW SPIROMETER | BZH | Substantially Equivalent | |
| K924146 | OH-500 OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | |
| K922623 | NEBULIZER SYSTEM | BTI | Substantially Equivalent | |
| K910118 | DATA RECORDER | FLL | Substantially Equivalent | |
| K903287 | MODEL 900S APNEA/HEART MONITOR | BZQ | Substantially Equivalent | |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | HFM | Substantially Equivalent | |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | DRT | Substantially Equivalent | |
| K890150 | H-3000 OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | |
| K881833 | NASAL CPAP SYSTEM | BYE | Substantially Equivalent | |
| K875031 | OXYGEN/PULSE MONITOR | DQA | Substantially Equivalent | |
| K874814 | HEALTHDYNE RATE METER | BZQ | Substantially Equivalent | |
| K874695 | HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 | DRT | Substantially Equivalent | |
| K861484 | INFANT MONITOR | BZQ | Substantially Equivalent | |
| K860254 | HEALTHDYNE'S EVENT RECORDER SYSTEM | BZQ | Substantially Equivalent | |
| K854374 | OXYGEN CONCENTRATOR, MODEL BX-5000 | CAW | Substantially Equivalent | |
| K853300 | HEALTHDYNE IMPLUSE VENTILATOR | CBK | Substantially Equivalent | |
| K843546 | INFANT MONITOR 16900 | BZQ | Substantially Equivalent | |
| K842207 | WAKO B.G. PRETEST STRIPS | CGA | Substantially Equivalent | |
| K841818 | IMPULSE VENTILATOR | CBK | Substantially Equivalent | |
| K833351 | DEMAND OXYGEN CONTROLLER | BZB | Substantially Equivalent | |
| K840345 | IMPULSE VENTILATOR | CBK | Substantially Equivalent | |
| K834099 | BLOOD GLUCOSE MONITOR | JJQ | Substantially Equivalent | |
| K822871 | MODEL BX-3000 OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | |
| K821612 | MODEL 16800 TREND RECORDER | DSF | Substantially Equivalent | |
| K821731 | HEALTHDYNE MODEL 16900 INFANT MONITOR | BZQ | Substantially Equivalent | |
| K820645 | INFANT MONITOR | BZQ | Substantially Equivalent | |
| K813254 | JET VENTILATOR | CBK | Substantially Equivalent | |
| K810255 | MEAN PRESSURE MONITOR | CAP | Substantially Equivalent | |
| K802583 | INFANT VENTILATOR, (RESPIRATOR) PLAN B | CBK | Substantially Equivalent | |
| K802205 | ECG/RESPIRATION STIMULATOR | BZQ | Substantially Equivalent | |
| K781926 | VENTILATOR, INFANT MODEL 100 | CBK | Substantially Equivalent | |
| K781530 | TEMPERATURE CONTROLLER MODEL 17000 | BZE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BZBCatheter, Nasal, Oxygen
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- BTICompressor, Air, Portable
- FLLContinuous Measurement Thermometer
- CAWGenerator, Oxygen, Portable
- CGAGlucose Oxidase, Glucose
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BZHMeter, Peak Flow, Spirometry
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- DQAOximeter
- DSFRecorder, Paper Chart
- OLVStandard Polysomnograph With Electroencephalograph
- CBKVentilator, Continuous, Facility Use
- BZDVentilator, Non-Continuous (Respirator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain