The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for T12s Telemetry Transmitter.
| Device ID | K081800 |
| 510k Number | K081800 |
| Device Name: | T12S TELEMETRY TRANSMITTER |
| Classification | Oximeter |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Laura Spiegelhoff |
| Correspondent | Laura Spiegelhoff MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-25 |
| Decision Date | 2008-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345025385 | K081800 | 000 |
| 00812345024968 | K081800 | 000 |
| 00812345023503 | K081800 | 000 |
| 00812345023497 | K081800 | 000 |
| 00812345023480 | K081800 | 000 |
| 00812345023466 | K081800 | 000 |
| 00812345023015 | K081800 | 000 |
| 00812345023008 | K081800 | 000 |