Aequitron Medical, Inc.
Walker, MI, US
Aequitron Medical, Inc. appears in FDA device records in Walker, MI. FDA records list 24 510(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
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Aequitron Medical, Inc. between 1984 and 1997. The busiest year on record is 1990, with 5. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 4 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 5 |
| 1991 | 2 |
| 1992 | 2 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K961972 | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR | BZQ | Substantially Equivalent - Subject to Tracking Reg. | |
| K952880 | MODEL LP-1000 VOLUME VENTILATOR | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K944654 | OXYGEN CONCENTRATION INDICATOR | CCL | Substantially Equivalent | |
| K914424 | MODEL 6213 REMOTE ALARM | CBK | Substantially Equivalent | |
| K915381 | PORTABLE OXYGEN GENERATOR | CAW | Substantially Equivalent | |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | DZD | Substantially Equivalent | |
| K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 | BZQ | Substantially Equivalent | |
| K905244 | MODEL LP6 VENTILATOR, MODIFICATION | CBK | Substantially Equivalent | |
| K903010 | CONTINUOUS VOLUME VENTILATOR MODEL LP10 | CBK | Substantially Equivalent | |
| K902785 | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON | BZQ | Substantially Equivalent | |
| K901656 | MODEL 9200 RESPIRATION/HEART RATE MONITOR | BZQ | Substantially Equivalent | |
| K901251 | MODEL 9101 RECORDER/ANALYZER SYSTEM | DSH | Substantially Equivalent | |
| K882080 | MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. | HFM | Substantially Equivalent | |
| K884637 | MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR | BZQ | Substantially Equivalent | |
| K881266 | MODEL 9216 RESPIRATION/HEART RATE MONITOR | BZQ | Substantially Equivalent | |
| K872954 | MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR | BZQ | Substantially Equivalent | |
| K871551 | MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR | BZQ | Substantially Equivalent | |
| K853856 | EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET | HFM | Substantially Equivalent | |
| K853084 | MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) | BZQ | Substantially Equivalent | |
| K850181 | AEQUITRON MED-7100 PHOTOTHERAPY LIGHT | LBI | Substantially Equivalent | |
| K840358 | IMPEDANCE/8200 MONITOR-MODEL 8300 | KRC | Substantially Equivalent | |
| K841363 | HEART RATE/RESPIRATION SIMULATOR 8310 | DRT | Substantially Equivalent | |
| K833349 | EVENT TAPE RECORDER 8293 | DSH | Substantially Equivalent | |
| K833348 | RESPIRATION/8100-HEART RATE RECORDER | DSH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- CAWGenerator, Oxygen, Portable
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- DSHRecorder, Magnetic Tape, Medical
- KRCTester, Electrode, Surface, Electrocardiographic
- DZDTube, Orthodontic
- LBIUnit, Neonatal Phototherapy
- CBKVentilator, Continuous, Facility Use
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