FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMBINATION CAMERA/LIGHT SOURCE
K Number: K951386
·
Decision Jun 30, 1995
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
11
Review Days
95
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Basic Information
- Device Name
- COMBINATION CAMERA/LIGHT SOURCE
- K Number
- K951386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- M.P. Video, Inc.
- Date Received
- March 27, 1995
- Decision Date
- June 30, 1995
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by M.P. Video, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943342 | MEDICAM XENON LIGHT SOURCE | Oct 17, 1994 | Substantially Equivalent |
| K942358 | AUTOCLAVEABLE MEDICAM 900 DIGICON CAMERA | Aug 8, 1994 | Substantially Equivalent |
| K941773 | MEDICAM 900 REMOTE | Jul 18, 1994 | Substantially Equivalent |
| K941693 | MEDICAM ENDOCOUPLER AND BEAMSPLITTER | Jun 27, 1994 | Substantially Equivalent |
| K893828 | ML-800 AUTOELECTRONIC LIGHT SOURCE | Jul 24, 1989 | Substantially Equivalent |
| K882924 | MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS | Jul 26, 1988 | Substantially Equivalent |
| K871595 | SURGICAL CAMERA ACCESSORIES | May 7, 1987 | Substantially Equivalent |
| K871057 | MC-SERIES SURGICAL CAMERAS | Apr 3, 1987 | Substantially Equivalent |
| K871056 | MEDICAM S-4 SURGICAL CAMERA | Mar 31, 1987 | Substantially Equivalent |
| K820829 | MEDICAM | May 3, 1982 | Substantially Equivalent |