Air-Shields, Inc.
Mchenry, IL, US
Air-Shields, Inc. appears in FDA device records in Mchenry, IL. FDA records list 33 510(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
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Air-Shields, Inc. between 1976 and 1998. The busiest year on record is 1978, with 5. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 2 |
| 1978 | 5 |
| 1983 | 1 |
| 1984 | 2 |
| 1986 | 2 |
| 1987 | 3 |
| 1988 | 3 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K974248 | WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM | HGM | Substantially Equivalent | |
| K972309 | JM-102 JAUNDICE METER | MQM | Substantially Equivalent | |
| K971256 | DUO-LITE PHOTOTHERAPY SYSTEM | LBI | Substantially Equivalent | |
| K960980 | ISOLETTE INFANT INCUBATOR | FMZ | Substantially Equivalent | |
| K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | KLK | Substantially Equivalent | |
| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | FMT | Substantially Equivalent | |
| K940975 | C450/C400 INFANT INCUBATORS | FMZ | Substantially Equivalent | |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | FPL | Substantially Equivalent | |
| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | FMZ | Substantially Equivalent | |
| K922150 | EXAMINATION LAMP | KZF | Substantially Equivalent | |
| K914864 | MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR | FMZ | Substantially Equivalent | |
| K913291 | MODEL C386 ISOLETTE(R) INFANT INCUBATOR | FMZ | Substantially Equivalent | |
| K874326 | SYSTEM VI MONITOR | DPS | Substantially Equivalent | |
| K880781 | DATALOGGER CHART RECORDER | DSF | Substantially Equivalent | |
| K875270 | INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS | FMT | Substantially Equivalent | |
| K872742 | WARM WEIGH MODELS I-20/W-30 INFANT SCALE | FMT | Substantially Equivalent | |
| K871594 | BIRTHING ROOM WARMER | FMT | Substantially Equivalent | |
| K870888 | WARM WEIGH MODEL N-10 INFANT SCALE | FRW | Substantially Equivalent | |
| K861781 | DELIVERY ROOM WARMER | FMT | Substantially Equivalent | |
| K861743 | AS165 RESPIRATION MONITOR | BZQ | Substantially Equivalent | |
| K842321 | AIR SHIELDS AS461 MONITORING SYS | DRT | Substantially Equivalent | |
| K840454 | PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO | LBI | Substantially Equivalent | |
| K832754 | MONITORING SYSTEM AS100-AS115 RECORD | DSF | Substantially Equivalent | |
| K781876 | ISOLETTE INCUBATOR | FMZ | Substantially Equivalent | |
| K781276 | X-RAY, PORTABLE | IZL | Substantially Equivalent | |
| K780876 | ULTRASONIC IMAGER | HEM | Substantially Equivalent | |
| K780472 | INFANT INCUBATOR | FMZ | Substantially Equivalent | |
| K780503 | INFUSION PUMP | FRN | Substantially Equivalent | |
| K771541 | FETAL MONITORING SYSTEM | HGM | Substantially Equivalent | |
| K771350 | AMBU RESUSCITATOR | BTM | Substantially Equivalent | |
| K760872 | PHOTOTHERAPY LIGHT | LBI | Substantially Equivalent | |
| K760663 | MVP-10 PEDIATRIC/NEONATAL VENTILATOR | CBK | Substantially Equivalent | |
| K760104 | RESPIRATION MONITOR | FLS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- KZFDevice, Medical Examination, Ac Powered
- DPSElectrocardiograph
- HEMImager, Ultrasonic Obstetric-Gynecologic
- FMZIncubator, Neonatal
- FPLIncubator, Neonatal Transport
- FLSMonitor, Apnea, Facility Use
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- FRNPump, Infusion
- DSFRecorder, Paper Chart
- FRWScale, Patient
- HGMSystem, Monitoring, Perinatal
- IZLSystem, X-Ray, Mobile
- LBIUnit, Neonatal Phototherapy
- CBKVentilator, Continuous, Facility Use
- BTMVentilator, Emergency, Manual (Resuscitator)
- FMTWarmer, Infant Radiant
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