The following data is part of a premarket notification filed by Estill Medical Technologies, Inc. with the FDA for Thermal Angel.
Device ID | K984640 |
510k Number | K984640 |
Device Name: | THERMAL ANGEL |
Classification | Warmer, Blood, Non-electromagnetic Radiation |
Applicant | ESTILL MEDICAL TECHNOLOGIES, INC. 17440 NORTH DALLAS PKWY.0 STE.100 Dallas, TX 75287 -7307 |
Contact | Thomas Kistner |
Correspondent | Thomas Kistner ESTILL MEDICAL TECHNOLOGIES, INC. 17440 NORTH DALLAS PKWY.0 STE.100 Dallas, TX 75287 -7307 |
Product Code | BSB |
CFR Regulation Number | 864.9205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-31 |
Decision Date | 1999-07-01 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERMAL ANGEL 75924709 2471331 Live/Registered |
ESTILL MEDICAL TECHNOLOGIES, INC. 2000-02-22 |