Company ยท US
Air-Shields, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1998. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMZ | Incubator, Neonatal | 7 |
| FMT | Warmer, Infant Radiant | 5 |
| LBI | Unit, Neonatal Phototherapy | 3 |
| DSF | Recorder, Paper Chart | 2 |
| HGM | System, Monitoring, Perinatal | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
| BZQ | Monitor, Breathing Frequency | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 |
| DPS | Electrocardiograph | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 |
| FPL | Incubator, Neonatal Transport | 1 |
| FRN | Pump, Infusion | 1 |
| FRW | Scale, Patient | 1 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 |
| IZL | System, X-Ray, Mobile | 1 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 1 |
| KZF | Device, Medical Examination, Ac Powered | 1 |
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 1998 | K974248 | WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM Air-Shields, Inc. | HGM |
| Sep 22, 1998 | K972309 | JM-102 JAUNDICE METER Air-Shields, Inc. | MQM |
| Sep 24, 1997 | K971256 | DUO-LITE PHOTOTHERAPY SYSTEM Air-Shields, Inc. | LBI |
| Jul 30, 1996 | K960980 | ISOLETTE INFANT INCUBATOR Air-Shields, Inc. | FMZ |
| Jan 17, 1996 | K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE Air-Shields, Inc. | KLK |
| May 3, 1995 | K940951 | RW RESUCITAIRE INFANT RADIANT WARMER Air-Shields, Inc. | FMT |
| Jun 23, 1994 | K940975 | C450/C400 INFANT INCUBATORS Air-Shields, Inc. | FMZ |
| Jun 10, 1994 | K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR Air-Shields, Inc. | FPL |
| Feb 5, 1993 | K924170 | ISOLETTE INCUBATOR HUMIDITY METER Air-Shields, Inc. | FMZ |
| Jul 21, 1992 | K922150 | EXAMINATION LAMP Air-Shields, Inc. | KZF |
| Mar 13, 1992 | K914864 | MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR Air-Shields, Inc. | FMZ |
| Nov 13, 1991 | K913291 | MODEL C386 ISOLETTE(R) INFANT INCUBATOR Air-Shields, Inc. | FMZ |
| Dec 5, 1988 | K874326 | SYSTEM VI MONITOR Air-Shields, Inc. | DPS |
| May 11, 1988 | K880781 | DATALOGGER CHART RECORDER Air-Shields, Inc. | DSF |
| Jan 19, 1988 | K875270 | INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS Air-Shields, Inc. | FMT |
| Oct 20, 1987 | K872742 | WARM WEIGH MODELS I-20/W-30 INFANT SCALE Air-Shields, Inc. | FMT |
| Jun 5, 1987 | K871594 | BIRTHING ROOM WARMER Air-Shields, Inc. | FMT |
| Mar 17, 1987 | K870888 | WARM WEIGH MODEL N-10 INFANT SCALE Air-Shields, Inc. | FRW |
| Jul 15, 1986 | K861781 | DELIVERY ROOM WARMER Air-Shields, Inc. | FMT |
| May 9, 1986 | K861743 | AS165 RESPIRATION MONITOR Air-Shields, Inc. | BZQ |
| Aug 3, 1984 | K842321 | AIR SHIELDS AS461 MONITORING SYS Air-Shields, Inc. | DRT |
| Mar 23, 1984 | K840454 | PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO Air-Shields, Inc. | LBI |
| Dec 22, 1983 | K832754 | MONITORING SYSTEM AS100-AS115 RECORD Air-Shields, Inc. | DSF |
| Dec 7, 1978 | K781876 | ISOLETTE INCUBATOR Air-Shields, Inc. | FMZ |
| Aug 10, 1978 | K781276 | X-RAY, PORTABLE Air-Shields, Inc. | IZL |
| Jun 27, 1978 | K780876 | ULTRASONIC IMAGER Air-Shields, Inc. | HEM |
| Apr 19, 1978 | K780472 | INFANT INCUBATOR Air-Shields, Inc. | FMZ |
| Apr 10, 1978 | K780503 | INFUSION PUMP Air-Shields, Inc. | FRN |
| Aug 25, 1977 | K771541 | FETAL MONITORING SYSTEM Air-Shields, Inc. | HGM |
| Aug 19, 1977 | K771350 | AMBU RESUSCITATOR Air-Shields, Inc. | BTM |
| Nov 2, 1976 | K760872 | PHOTOTHERAPY LIGHT Air-Shields, Inc. | LBI |
| Sep 27, 1976 | K760663 | MVP-10 PEDIATRIC/NEONATAL VENTILATOR Air-Shields, Inc. | CBK |
| Sep 21, 1976 | K760104 | RESPIRATION MONITOR Air-Shields, Inc. | FLS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||