FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST
K Number: K904691
·
Decision Feb 19, 1991
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
22
Applicant Total
9
Review Days
126
Basic Information
- Device Name
- AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST
- K Number
- K904691
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- AIR-SHIELDS VICKERS, INC.
- Date Received
- October 16, 1990
- Decision Date
- February 19, 1991
- Product Code
- HFM
- 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 |
|---|---|---|---|
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by AIR-SHIELDS VICKERS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K924679 | OXYCARE(TM) OXYGEN CONTROLLER/MONITOR | Feb 21, 1995 | Substantially Equivalent |
| K924297 | DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER | Mar 18, 1993 | Substantially Equivalent |
| K912908 | AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM | Dec 13, 1991 | Substantially Equivalent |
| K912909 | SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM | Nov 5, 1991 | Substantially Equivalent |
| K912910 | C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM | Oct 30, 1991 | Substantially Equivalent |
| K903378 | MODEL C286 ISOLETTE INFANT INCUBATOR | Oct 15, 1990 | Substantially Equivalent |
| K895782 | NEONATAL INCUBATOR (ACCESSORY) | Dec 7, 1989 | Substantially Equivalent |
| K884086 | C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR | Nov 14, 1988 | Substantially Equivalent |