The following data is part of a premarket notification filed by International Biomedical, Inc. with the FDA for Modification To Infant Life Support Module-20.
| Device ID | K022876 |
| 510k Number | K022876 |
| Device Name: | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 |
| Classification | Incubator, Neonatal Transport |
| Applicant | INTERNATIONAL BIOMEDICAL, INC. 8508 CROSS PARK DR. Austin, TX 78754 |
| Contact | Gerlad Manning |
| Correspondent | Gerlad Manning INTERNATIONAL BIOMEDICAL, INC. 8508 CROSS PARK DR. Austin, TX 78754 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-30 |
| Decision Date | 2002-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865648000320 | K022876 | 000 |