The following data is part of a premarket notification filed by Critical Patient Care, Inc. with the FDA for Critical Care Assessment.
Device ID | K101983 |
510k Number | K101983 |
Device Name: | CRITICAL CARE ASSESSMENT |
Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
Applicant | CRITICAL PATIENT CARE, INC. 4005 BLACKHAWK STREET Endinburg, TX 78539 |
Contact | Marie Cosgrove |
Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | JOM |
CFR Regulation Number | 870.2780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-07-14 |
Decision Date | 2010-09-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRITICAL CARE ASSESSMENT 85233102 4031303 Live/Registered |
Critical Patient Care, Inc. 2011-02-03 |
CRITICAL CARE ASSESSMENT 77867301 not registered Dead/Abandoned |
Critical Patient Care, Inc. 2009-11-06 |