The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Respiratory Support System, Neonatal.
| Device ID | K760340 |
| 510k Number | K760340 |
| Device Name: | RESPIRATORY SUPPORT SYSTEM, NEONATAL |
| Classification | Monitor, Breathing Frequency |
| Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-30 |
| Decision Date | 1976-08-11 |