The following data is part of a premarket notification filed by Atom Medical Corporation with the FDA for Atom Transcapsule V-707.
| Device ID | K123937 |
| 510k Number | K123937 |
| Device Name: | ATOM TRANSCAPSULE V-707 |
| Classification | Incubator, Neonatal Transport |
| 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 | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854401006310 | K123937 | 000 |
| 00854401006327 | K123937 | 000 |
| 05055931132042 | K123937 | 000 |
| 05055931111146 | K123937 | 000 |