The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Bos-2s, Spiraflo Bubble Infant Oxygen..
Device ID | K823273 |
510k Number | K823273 |
Device Name: | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-02 |
Decision Date | 1983-01-05 |