The following data is part of a premarket notification filed by Deltatherm with the FDA for Delta Therm Cold Therapy System.
Device ID | K945399 |
510k Number | K945399 |
Device Name: | DELTA THERM COLD THERAPY SYSTEM |
Classification | Pack, Hot Or Cold, Water Circulating |
Applicant | DELTATHERM 7038 RIVER RD. Pittsburgh, PA 15225 |
Contact | Kirk A Dobbs |
Correspondent | Kirk A Dobbs DELTATHERM 7038 RIVER RD. Pittsburgh, PA 15225 |
Product Code | ILO |
CFR Regulation Number | 890.5720 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-04 |
Decision Date | 1995-03-07 |