FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOTOGRAPHIC EQUIPMENT
K Number: K812201
·
Decision Oct 19, 1981
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
3
Applicant Total
9
Review Days
76
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Basic Information
- Device Name
- PHOTOGRAPHIC EQUIPMENT
- K Number
- K812201
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Reznik Instruments
- Date Received
- August 4, 1981
- Decision Date
- October 19, 1981
- Product Code
- FEM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- RA
- 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
POLAROID INSTANT ENDOCAMERA
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
POLAROID LAND CAMERA FOR ENDOSCOPY
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Reznik Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K812205 | FORCEP | Oct 26, 1981 | Substantially Equivalent |
| K812203 | ELECTROSURGICAL UNIT | Oct 13, 1981 | Substantially Equivalent |
| K812206 | LAPAROSCOPE | Oct 13, 1981 | Substantially Equivalent |
| K812199 | TROCAR & TROCAR SLEEVES | Oct 13, 1981 | Substantially Equivalent |
| K812204 | UTERINE MANIPULATORS | Oct 13, 1981 | Substantially Equivalent |
| K812200 | INSUFFLATOR | Sep 29, 1981 | Substantially Equivalent |
| K812202 | FIBER OPTIC LIGHT SOURCE | Sep 29, 1981 | Substantially Equivalent |
| K812198 | ACCESSORIES(PROBES, SUCTION TUBES, ETC.) | Sep 11, 1981 | Substantially Equivalent |