The following data is part of a premarket notification filed by Estill Medical Technologies, Inc. with the FDA for Modification To Thermal Angel.
| Device ID | K012031 |
| 510k Number | K012031 |
| Device Name: | MODIFICATION TO THERMAL ANGEL |
| Classification | Warmer, Blood, Non-electromagnetic Radiation |
| Applicant | ESTILL MEDICAL TECHNOLOGIES, INC. 4144 NORTH CENTRAL EXPRESSWAY SUITE 260 Dallas, TX 75204 |
| Contact | Daniel T Kistner |
| Correspondent | Daniel T Kistner ESTILL MEDICAL TECHNOLOGIES, INC. 4144 NORTH CENTRAL EXPRESSWAY SUITE 260 Dallas, TX 75204 |
| Product Code | BSB |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-28 |
| Decision Date | 2001-07-26 |
| Summary: | summary |