The following data is part of a premarket notification filed by Mountain Medical Equipment, Inc. with the FDA for Alpine.
Device ID | K864005 |
510k Number | K864005 |
Device Name: | ALPINE |
Classification | Generator, Oxygen, Portable |
Applicant | MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127 |
Contact | James W Morgan |
Correspondent | James W Morgan MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-15 |
Decision Date | 1987-01-28 |