510(k) K832899
K832899 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ZIMMER OSSIMETER". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 1983
- Date Received
- August 29, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tape, Measuring, Rulers And Calipers
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type