The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Meddars/ultra Imager Pulse/phon Module.
| Device ID | K811626 |
| 510k Number | K811626 |
| Device Name: | MEDDARS/ULTRA IMAGER PULSE/PHON MODULE |
| Classification | Phonocardiograph |
| Applicant | HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-09 |
| Decision Date | 1981-07-01 |