510(k) K905393
K905393 is an FDA 510(k) premarket notification submitted by Frigitronics, Inc. for the device "HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR". The FDA issued a decision of Substantially Equivalent on January 16, 1991. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Frigitronics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 1991
- Date Received
- November 30, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Endoscopic, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type