MFE CARDIAC STRESS SYSTEM
FDA 510(k) clearance K850868 · decided 1985-06-12
Clearance details
- K-number
- K850868
- Device name
- MFE CARDIAC STRESS SYSTEM
- Applicant
- Ketronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-01
- Decision date
- 1985-06-12
- Days to decision
- 103 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- The Netherlands, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.