The following data is part of a premarket notification filed by Intl. Biomedical Concepts, Inc. with the FDA for Mobile Pak, Model Dc.
Device ID | K880262 |
510k Number | K880262 |
Device Name: | MOBILE PAK, MODEL DC |
Classification | Generator, Oxygen, Portable |
Applicant | INTL. BIOMEDICAL CONCEPTS, INC. 2955 SOUTH TEJON Englewood, CO 80110 |
Contact | Georgi, Iii |
Correspondent | Georgi, Iii INTL. BIOMEDICAL CONCEPTS, INC. 2955 SOUTH TEJON Englewood, CO 80110 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-22 |
Decision Date | 1988-02-12 |