The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Zimmer A.t.s. 4000ts Automatic Tourniquet System.
| Device ID | K123553 |
| 510k Number | K123553 |
| Device Name: | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM |
| Classification | Tourniquet, Pneumatic |
| Applicant | ZIMMER INC. 9001 WESLEYAN ROAD, SUITE 200 Indianapolis, IN 46268 |
| Contact | Allison Scott, Rac |
| Correspondent | Allison Scott, Rac ZIMMER INC. 9001 WESLEYAN ROAD, SUITE 200 Indianapolis, IN 46268 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-19 |
| Decision Date | 2013-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024420243 | K123553 | 000 |
| 00889024420113 | K123553 | 000 |
| 00889024420120 | K123553 | 000 |
| 00889024420137 | K123553 | 000 |
| 00889024420144 | K123553 | 000 |
| 00889024420151 | K123553 | 000 |
| 00889024420168 | K123553 | 000 |
| 00889024420175 | K123553 | 000 |
| 00889024420182 | K123553 | 000 |
| 00889024420199 | K123553 | 000 |
| 00889024420205 | K123553 | 000 |
| 00889024420212 | K123553 | 000 |
| 00889024420229 | K123553 | 000 |
| 00889024420236 | K123553 | 000 |
| 00889024376731 | K123553 | 000 |