The following data is part of a premarket notification filed by Cryogenic Assoc. with the FDA for Stroller Sprint.
Device ID | K841808 |
510k Number | K841808 |
Device Name: | STROLLER SPRINT |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | CRYOGENIC ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-01 |
Decision Date | 1984-05-16 |