510(k) K961971
K961971 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "Q-5000". The FDA issued a decision of Substantially Equivalent on June 28, 1996. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Stryker Endoscopy has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1996
- Date Received
- May 20, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Floor Standing
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type