The following data is part of a premarket notification filed by International Biomedical, Ltd. with the FDA for 185a+ Transport Incubator With Masimo Pulseox, 185a+ Transport Incubator With Nellcor Pulseox.
Device ID | K103523 |
510k Number | K103523 |
Device Name: | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
Classification | Incubator, Neonatal Transport |
Applicant | INTERNATIONAL BIOMEDICAL, LTD. 8508 CROSS PARK DR. Austin, TX 78754 |
Contact | Amy Pieper |
Correspondent | Amy Pieper INTERNATIONAL BIOMEDICAL, LTD. 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 | 2010-12-01 |
Decision Date | 2011-05-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00868406000037 | K103523 | 000 |