The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Transonic Flow-qc Set Model Adt1010.
| Device ID | K021571 |
| 510k Number | K021571 |
| Device Name: | TRANSONIC FLOW-QC SET MODEL ADT1010 |
| Classification | System, Hemodialysis, Access Recirculation Monitoring |
| Applicant | TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Product Code | MQS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-14 |
| Decision Date | 2002-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877466005791 | K021571 | 000 |
| 08774660005805 | K021571 | 000 |
| 08774660005799 | K021571 | 000 |
| 08774660000473 | K021571 | 000 |
| 08774660000466 | K021571 | 000 |