FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR
K Number: K905393
·
Decision Jan 16, 1991
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
22
Applicant Total
3
Review Days
47
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR
- K Number
- K905393
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Frigitronics, Inc.
- Date Received
- November 30, 1990
- Decision Date
- January 16, 1991
- Product Code
- FWF
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWF), ordered by most recent decision date.
FLEXISCOPE, MODELS 50MH AND 50 MHC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VES 1501-M
FDA 510(k)
FDA Class 1
·General, Plastic Surgery