The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Emerson Model 3mv-ap And 3v-ap Press-.
Device ID | K832271 |
510k Number | K832271 |
Device Name: | EMERSON MODEL 3MV-AP AND 3V-AP PRESS- |
Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
Applicant | J. H. EMERSON CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAP |
CFR Regulation Number | 868.2600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-12 |
Decision Date | 1983-09-12 |