The following data is part of a premarket notification filed by Astral, Ltd. with the FDA for Astral Disposable Skin Temperature Probe.
| Device ID | K946005 |
| 510k Number | K946005 |
| Device Name: | ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE |
| Classification | Warmer, Infant Radiant |
| Applicant | ASTRAL, LTD. 1114 BENFIELD BLVD., SUITE K Millersville, MD 21108 |
| Contact | Earl D Marquette Jr. |
| Correspondent | Earl D Marquette Jr. ASTRAL, LTD. 1114 BENFIELD BLVD., SUITE K Millersville, MD 21108 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-09 |
| Decision Date | 1995-09-25 |