Air-Shields, Inc.
Medical device manufacturer in Hatboro, PA.
33510(k) clearances
0PMA approvals
0recalls
Device types
- FMZ Incubator, Neonatal 7
- FMT Warmer, Infant Radiant 5
- LBI Unit, Neonatal Phototherapy 3
- HGM System, Monitoring, Perinatal 2
- DSF Recorder, Paper Chart 2
- MQM Bilirubin (Total And Unbound) In The… 1
- FLS Monitor, Apnea, Facility Use 1
- KLK Monitor, Oxygen, Cutaneous, For Infant Not… 1
- FPL Incubator, Neonatal Transport 1
- KZF Device, Medical Examination, Ac Powered 1
- DPS Electrocardiograph 1
- FRW Scale, Patient 1
- BZQ Monitor, Breathing Frequency 1
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 1
- IZL System, X-Ray, Mobile 1
- HEM Imager, Ultrasonic Obstetric-Gynecologic 1
- FRN Pump, Infusion 1
- BTM Ventilator, Emergency, Manual (Resuscitator) 1
- CBK Ventilator, Continuous, Facility Use 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K974248 | Watchchild Obsterical Patient Data Management SystemHGM · Traditional | 10/07/1998SE |
| K972309 | JM-102 Jaundice MeterMQM · Traditional | 09/22/1998SE |
| K971256 | Duo-Lite Phototherapy SystemLBI · Traditional | 09/24/1997SE |
| K960980 | Isolette Infant IncubatorFMZ · Traditional | 07/30/1996SE |
| K924709 | Satcare Oxygen Controller/Monitor W/ Pulse OximeteKLK · Traditional | 01/17/1996SE |
| K940951 | RW Resucitaire Infant Radiant WarmerFMT · Traditional | 05/03/1995SE |
| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
| K941106 | Model TI500 Isolette Infant IncubatorFPL · Traditional | 06/10/1994SE |
| K924170 | Isolette Incubator Humidity MeterFMZ · Traditional | 02/05/1993SE |
| K922150 | Examination LampKZF · Traditional | 07/21/1992SE |
| K914864 | Models C500/C550 Isolete(R) Infant IncubatorFMZ · Traditional | 03/13/1992SE |
| K913291 | Model C386 Isolette(R) Infant IncubatorFMZ · Traditional | 11/13/1991SE |
| K874326 | System Vi MonitorDPS · Traditional | 12/05/1988SE |
| K880781 | Datalogger Chart RecorderDSF · Traditional | 05/11/1988SE |
| K875270 | Infant Intensive Care System Vertical Height AdjusFMT · Traditional | 01/19/1988SE |
| K872742 | Warm Weigh Models I-20/W-30 Infant ScaleFMT · Traditional | 10/20/1987SE |
| K871594 | Birthing Room WarmerFMT · Traditional | 06/05/1987SE |
| K870888 | Warm Weigh Model N-10 Infant ScaleFRW · Traditional | 03/17/1987SE |
| K861781 | Delivery Room WarmerFMT · Traditional | 07/15/1986SE |
| K861743 | AS165 Respiration MonitorBZQ · Traditional | 05/09/1986SE |
| K842321 | Air Shields AS461 Monitoring SysDRT · Traditional | 08/03/1984SE |
| K840454 | Phototherapy Unit 7850 Neonatal PhotoLBI · Traditional | 03/23/1984SE |
| K832754 | Monitoring System AS100-AS115 RecordDSF · Traditional | 12/22/1983SE |
| K781876 | Isolette IncubatorFMZ · Traditional | 12/07/1978SE |
| K781276 | X-Ray, PortableIZL · Traditional | 08/10/1978SE |
| K780876 | Ultrasonic ImagerHEM · Traditional | 06/27/1978SE |
| K780472 | Infant IncubatorFMZ · Traditional | 04/19/1978SE |
| K780503 | Infusion PumpFRN · Traditional | 04/10/1978SE |
| K771541 | Fetal Monitoring SystemHGM · Traditional | 08/25/1977SE |
| K771350 | Ambu ResuscitatorBTM · Traditional | 08/19/1977SE |
| K760872 | Phototherapy LightLBI · Traditional | 11/02/1976SE |
| K760663 | MVP-10 Pediatric/Neonatal VentilatorCBK · Traditional | 09/27/1976SE |
| K760104 | Respiration MonitorFLS · Traditional | 09/21/1976SE |