Zoll M Series ETCO2 Option
510(k) K993036
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)ST | NumberK993036 | Date28 Feb 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- ST
Overview
AI-generated summary, 18 Sep 2026
The Zoll M Series ETCO₂ Option is an automated external defibrillator (non-wearable) with an integrated end-tidal carbon dioxide (ETCO₂) monitoring capability. It provides continuous, noninvasive measurement of ETCO₂ and respiration rate, enabling real-time assessment of ventilatory function and metabolic status in patients.
This device is supplied as an add-on option for the M Series monitor/defibrillator platform and is intended for use in prehospital, emergency department, and critical care settings. It is classified as a Class III medical device under FDA regulation 870.5310 and requires a Premarket Approval (PMA) pathway, though this submission was cleared under a 510(k) with tracking. The device incorporates a Capnostat® sensor and Novametrix technology for ETCO₂ monitoring, with no specific sterility or single-use designation noted in the data.