The following data is part of a premarket notification filed by Aragona Medical, Inc. with the FDA for Mtc Xi Ul.
| Device ID | K871178 |
| 510k Number | K871178 |
| Device Name: | MTC XI UL |
| Classification | Warmer, Infant Radiant |
| Applicant | ARAGONA MEDICAL, INC. 59 HERITAGE COURT Woodcliff Lake, NJ 07675 |
| Contact | Michael Ugander |
| Correspondent | Michael Ugander ARAGONA MEDICAL, INC. 59 HERITAGE COURT Woodcliff Lake, NJ 07675 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-24 |
| Decision Date | 1987-10-09 |