The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll M Series Nibp Option.
Device ID | K032363 |
510k Number | K032363 |
Device Name: | ZOLL M SERIES NIBP OPTION |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Sean Reynolds |
Correspondent | Sean Reynolds ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-31 |
Decision Date | 2003-10-31 |
Summary: | summary |