The following data is part of a premarket notification filed by Pintler Medical with the FDA for Pintler Patient Warming System.
Device ID | K113705 |
510k Number | K113705 |
Device Name: | PINTLER PATIENT WARMING SYSTEM |
Classification | System, Thermal Regulating |
Applicant | PINTLER MEDICAL 3220 S. HANFORD STREET Seattle, WA 98144 |
Contact | Maribeth Macintyre-ellis |
Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | DWJ |
CFR Regulation Number | 870.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-12-16 |
Decision Date | 2012-08-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B389PPWS0011 | K113705 | 000 |