The following data is part of a premarket notification filed by International Biomedical with the FDA for Puffin Lite Infant Resuscitation System.
Device ID | K182956 |
510k Number | K182956 |
Device Name: | Puffin Lite Infant Resuscitation System |
Classification | Ventilator, Emergency, Powered (resuscitator) |
Applicant | International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
Contact | Amy Pieper |
Correspondent | Amy Pieper International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
Product Code | BTL |
CFR Regulation Number | 868.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-24 |
Decision Date | 2019-01-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00865648000344 | K182956 | 000 |