RESTROSPECTIVE ECG MEMORY MODULE
FDA 510(k) clearance K831406 · decided 1983-07-07
Clearance details
- K-number
- K831406
- Device name
- RESTROSPECTIVE ECG MEMORY MODULE
- Applicant
- Cardiac Evaluation Center, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-02
- Decision date
- 1983-07-07
- Days to decision
- 66 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.