The following data is part of a premarket notification filed by International Biomedical with the FDA for Lifeborne Infant Resuscitator.
Device ID | K140707 |
510k Number | K140707 |
Device Name: | LIFEBORNE INFANT RESUSCITATOR |
Classification | Ventilator, Emergency, Powered (resuscitator) |
Applicant | INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin, TX 78754 |
Contact | Amy Pieper |
Correspondent | Amy Pieper INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin, TX 78754 |
Product Code | BTL |
CFR Regulation Number | 868.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-20 |
Decision Date | 2014-05-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00868406000051 | K140707 | 000 |