The following data is part of a premarket notification filed by International Biomedical with the FDA for Infatherm Disposable Infant Warming Mattress.
Device ID | K221653 |
510k Number | K221653 |
Device Name: | InfaTherm Disposable Infant Warming Mattress |
Classification | Pack, Hot Or Cold, Disposable |
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 | IMD |
CFR Regulation Number | 890.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-06-07 |
Decision Date | 2022-10-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850018561587 | K221653 | 000 |