The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Ambulatory X-12 Telemetry Module.
| Device ID | K974149 |
| 510k Number | K974149 |
| Device Name: | AMBULATORY X-12 TELEMETRY MODULE |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Scott J Pease |
| Correspondent | Scott J Pease MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-04 |
| Decision Date | 1998-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094272581 | K974149 | 000 |
| 00732094283464 | K974149 | 000 |