The following data is part of a premarket notification filed by International Biomedics, Inc. with the FDA for Modification To Transport Incubator 185.
| Device ID | K031096 |
| 510k Number | K031096 |
| Device Name: | MODIFICATION TO TRANSPORT INCUBATOR 185 |
| Classification | Incubator, Neonatal Transport |
| Applicant | INTERNATIONAL BIOMEDICS, INC. 8508 CROSS PARK DR. Austin, TX 78754 |
| Contact | Gerald Manning |
| Correspondent | Gerald Manning INTERNATIONAL BIOMEDICS, 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 | 2003-04-07 |
| Decision Date | 2003-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868406000099 | K031096 | 000 |