FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 533 PHOTOTHERAPY UNIT
K Number: K810953
·
Decision Apr 23, 1981
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
19
Review Days
16
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Basic Information
- Device Name
- MODEL 533 PHOTOTHERAPY UNIT
- K Number
- K810953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Narco Air-Shields
- Date Received
- April 7, 1981
- Decision Date
- April 23, 1981
- Product Code
- LBI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | FDA class 2 | General Hospital |
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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 |
| 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 |
| K790552 | AS7 & AS8 MONITORS | May 1, 1979 | Substantially Equivalent |
| K790551 | TRANSPORT INCUBATOR | Apr 24, 1979 | Substantially Equivalent |