ZOLL AUTOCLAVABLE INTERNAL HANDLES
FDA 510(k) clearance K963781 · decided 1997-05-20
Clearance details
- K-number
- K963781
- Device name
- ZOLL AUTOCLAVABLE INTERNAL HANDLES
- Applicant
- Zoll Medical Corp
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1996-09-20
- Decision date
- 1997-05-20
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.