The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll M Series Spo2 Option.
Device ID | K982992 |
510k Number | K982992 |
Device Name: | ZOLL M SERIES SPO2 OPTION |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
Contact | Maura Mcguire |
Correspondent | Maura Mcguire ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-27 |
Decision Date | 1999-03-11 |