MODIFICATION TO ZYMED HOLTER 2000
FDA 510(k) clearance K992197 · decided 1999-07-28
Clearance details
- K-number
- K992197
- Device name
- MODIFICATION TO ZYMED HOLTER 2000
- Applicant
- Zymed Medical Instrumentation
- Decision
- Substantially Equivalent
- Date received
- 1999-06-30
- Decision date
- 1999-07-28
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MLO
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Camarillo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.