The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll M Series Nibp Option, Model Mseries Nibp Option.
| Device ID | K002029 |
| 510k Number | K002029 |
| Device Name: | ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Contact | Paul Dias |
| Correspondent | Paul Dias ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-03 |
| Decision Date | 2000-09-21 |