The following data is part of a premarket notification filed by Zephyr Technology Corporation with the FDA for Biomodule 3-m1.
| Device ID | K123658 |
| 510k Number | K123658 |
| Device Name: | BIOMODULE 3-M1 |
| Classification | Electrode, Electrocardiograph |
| Applicant | ZEPHYR TECHNOLOGY CORPORATION 1151 HOPE STREET Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen ZEPHYR TECHNOLOGY CORPORATION 1151 HOPE STREET Stamford, CT 06907 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-28 |
| Decision Date | 2013-04-24 |
| Summary: | summary |