FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETAL MONITORING SYSTEM
K Number: K771541
·
Decision Aug 25, 1977
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
210
Applicant Total
33
Review Days
14
Basic Information
- Device Name
- FETAL MONITORING SYSTEM
- K Number
- K771541
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- AIR-SHIELDS, INC.
- Date Received
- August 11, 1977
- Decision Date
- August 25, 1977
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by AIR-SHIELDS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K974248 | WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM | Oct 7, 1998 | Substantially Equivalent |
| K972309 | JM-102 JAUNDICE METER | Sep 22, 1998 | Substantially Equivalent |
| K971256 | DUO-LITE PHOTOTHERAPY SYSTEM | Sep 24, 1997 | Substantially Equivalent |
| K960980 | ISOLETTE INFANT INCUBATOR | Jul 30, 1996 | Substantially Equivalent |
| K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | Jan 17, 1996 | Substantially Equivalent |
| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | May 3, 1995 | Substantially Equivalent |
| K940975 | C450/C400 INFANT INCUBATORS | Jun 23, 1994 | Substantially Equivalent |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Jun 10, 1994 | Substantially Equivalent |
| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | Feb 5, 1993 | Substantially Equivalent |
| K922150 | EXAMINATION LAMP | Jul 21, 1992 | Substantially Equivalent |