The following data is part of a premarket notification filed by Atom Medical Corporation with the FDA for Resusci Flow; Resusci Flow 104.
| Device ID | K102542 |
| 510k Number | K102542 |
| Device Name: | RESUSCI FLOW; RESUSCI FLOW 104 |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | ATOM MEDICAL CORPORATION 24301 WOODSTAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ATOM MEDICAL CORPORATION 24301 WOODSTAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-03 |
| Decision Date | 2011-04-06 |
| Summary: | summary |