FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POLAROID LAND CAMERA FOR ENDOSCOPY
K Number: K792512
·
Decision Dec 20, 1979
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
3
Applicant Total
5
Review Days
15
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Basic Information
- Device Name
- POLAROID LAND CAMERA FOR ENDOSCOPY
- K Number
- K792512
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Polaroid Corp.
- Date Received
- December 5, 1979
- Decision Date
- December 20, 1979
- Product Code
- FEM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FEM), ordered by most recent decision date.
CAMERA COVER WITH TEAR TIP
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PHOTOGRAPHIC EQUIPMENT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
POLAROID INSTANT ENDOCAMERA
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Polaroid Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K812542 | POLAROID INSTANT ENDOCAMERA | Oct 19, 1981 | Substantially Equivalent |
| K812088 | POLAROID RADIOGRAPHIC FILM PROCESSOR | Aug 31, 1981 | Substantially Equivalent |
| K812089 | POLAROID RADIOGRAPHIC FILM CASSETTE | Aug 31, 1981 | Substantially Equivalent |
| K811352 | POLAROID TPX RADIOGRAPHIC FILM | Jun 18, 1981 | Substantially Equivalent |