FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AS7 & AS8 MONITORS
K Number: K790552
·
Decision May 1, 1979
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
19
Review Days
42
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Basic Information
- Device Name
- AS7 & AS8 MONITORS
- K Number
- K790552
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Narco Air-Shields
- Date Received
- March 20, 1979
- Decision Date
- May 1, 1979
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Narco Air-Shields
| K Number | Device Name | ||
|---|---|---|---|
| K820114 | SYSTEM V.HEART RATE/RESPIR. RATE MONIT. | Feb 12, 1982 | Substantially Equivalent |
| K810953 | MODEL 533 PHOTOTHERAPY UNIT | Apr 23, 1981 | Substantially Equivalent |
| K810474 | PROBE COVER | Mar 31, 1981 | Substantially Equivalent |
| K802800 | NARCO AIR-SHEILDS SYS. 100 MONITOR SYS | Nov 24, 1980 | Substantially Equivalent |
| K802126 | ISOLETTE INCUBATOR C-100 | Sep 26, 1980 | Substantially Equivalent |
| K792592 | AMBU UNIVERSAL SUCTION PUMP | Jan 11, 1980 | Substantially Equivalent |
| K792499 | AMBU PAEDI ANAESTHESIA SYSTEM | Dec 19, 1979 | Substantially Equivalent |
| K792117 | AIR-SHIELDS HEART RATE MONITOR | Nov 13, 1979 | Substantially Equivalent |
| K792118 | AIR-SHIELDS RESUSCITATORS | Nov 13, 1979 | Substantially Equivalent |
| K790551 | TRANSPORT INCUBATOR | Apr 24, 1979 | Substantially Equivalent |