Zoll R Series
510(k) K081574
Zoll R Series is a Class II device made by Zoll Medical Corporation, cleared under FDA 510(k) K081574 on 18 Sep 2008, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081574 | Date18 Sep 2008 | StatusActive |
Official records
- FDA 510(k) database K081574
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LDD
- Device class
- Class II
- Regulation
- 21 CFR Part 870.5300
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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