The following data is part of a premarket notification filed by Mountain Medical Equipment, Inc. with the FDA for Econo-mist Portable Compressor Driven Nebulizer.
Device ID | K873677 |
510k Number | K873677 |
Device Name: | ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER |
Classification | Compressor, Air, Portable |
Applicant | MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127 |
Contact | James Morgan |
Correspondent | James Morgan MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-14 |
Decision Date | 1987-10-20 |