The following data is part of a premarket notification filed by Bio-dyne, Inc. with the FDA for Model 3500 Infant Respiration & Heart Rate Monitor.
| Device ID | K864261 |
| 510k Number | K864261 |
| Device Name: | MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | BIO-DYNE, INC. 36 HIGGINS DR. Milford, CT 06460 |
| Contact | James Walls |
| Correspondent | James Walls BIO-DYNE, INC. 36 HIGGINS DR. Milford, CT 06460 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-29 |
| Decision Date | 1987-03-27 |