The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Monitor, Respiratory (cpap).
Device ID | K760339 |
510k Number | K760339 |
Device Name: | MONITOR, RESPIRATORY (CPAP) |
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 | 1976-10-28 |