The following data is part of a premarket notification filed by Intl. Biomedical Concepts, Inc. with the FDA for Mobile Pak, Model Ac.
| Device ID | K880261 |
| 510k Number | K880261 |
| Device Name: | MOBILE PAK, MODEL AC |
| 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 |