510(k) K905117
K905117 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "ENDOSCOPE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on April 25, 1991. The device falls under product code GCI (Laryngoscope, Endoscope), a Class II device regulated under 21 CFR 876.1500. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1991
- Date Received
- November 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laryngoscope, Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type