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 |