The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Pocketcpr.
Device ID | K112660 |
510k Number | K112660 |
Device Name: | POCKETCPR |
Classification | Aid, Cardiopulmonary Resuscitation |
Applicant | ZOLL MEDICAL CORP. 525 NARRAGANSETT PARK DRIVE Pawtucket, RI 02861 |
Contact | Robert Morse |
Correspondent | Robert Morse ZOLL MEDICAL CORP. 525 NARRAGANSETT PARK DRIVE Pawtucket, RI 02861 |
Product Code | LIX |
CFR Regulation Number | 870.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-13 |
Decision Date | 2012-05-10 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POCKETCPR 77011381 3403749 Live/Registered |
ZOLL Medical Corporation 2006-10-01 |