510(k) K123553
K123553 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM". The FDA issued a decision of Substantially Equivalent on August 9, 2013. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2013
- Date Received
- November 19, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tourniquet, Pneumatic
- Device Class
- Class I
- Regulation Number
- 878.5910
- Review Panel
- SU
- Submission Type