The following data is part of a premarket notification filed by Statcorp Medical with the FDA for Ultracheck Spacelabs Abp Cuff-child, Ultracheck Spacelabs Abp Cuff-small Adult, Ultracheck Spacelabs Abp Cuff-adult, Ultracheck Spacelabs Abp Cuff-large Adult.
Device ID | K152801 |
510k Number | K152801 |
Device Name: | ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT |
Classification | Blood Pressure Cuff |
Applicant | STATCORP MEDICAL 14476 Duval Place West Suite 303 Jacksonville, FL 32218 |
Contact | Wayne Emmert |
Correspondent | Wayne Emmert STATCORP MEDICAL 14476 Duval Place West Suite 303 Jacksonville, FL 32218 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-28 |
Decision Date | 2015-10-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10841522102639 | K152801 | 000 |
10841522102615 | K152801 | 000 |
10841522102561 | K152801 | 000 |
10841522102660 | K152801 | 000 |
10841522128530 | K152801 | 000 |
10841522128523 | K152801 | 000 |
10841522128516 | K152801 | 000 |
10841522128509 | K152801 | 000 |