The following data is part of a premarket notification filed by Atom Medical Corporation with the FDA for Resuscitation Unit 105.
| Device ID | K103317 |
| 510k Number | K103317 |
| Device Name: | RESUSCITATION UNIT 105 |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | ATOM MEDICAL CORPORATION 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ATOM MEDICAL CORPORATION 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-10 |
| Decision Date | 2011-04-20 |
| Summary: | summary |