The following data is part of a premarket notification filed by Mcewen And Associates Consulting Ltd. with the FDA for Ats 5000 Automatic Tourniquet Instrument.
| Device ID | K202919 |
| 510k Number | K202919 |
| Device Name: | ATS 5000 Automatic Tourniquet Instrument |
| Classification | Tourniquet, Pneumatic |
| Applicant | McEwen And Associates Consulting Ltd. 207-1099 West 8th Avenue Vancouver, CA V6h 1c3 |
| Contact | Julie Kerr |
| Correspondent | Julie Kerr McEwen And Associates Consulting Ltd. 207-1099 West 8th Avenue Vancouver, CA V6h 1c3 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024626454 | K202919 | 000 |