MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
FDA 510(k) clearance K990266 · decided 1999-02-02
Clearance details
- K-number
- K990266
- Device name
- MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
- Applicant
- Micromedical Industries, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-28
- Decision date
- 1999-02-02
- Days to decision
- 5 days
- Clearance type
- Special
- Product code
- LOS
- Advisory committee
- Unknown
- Location
- Northfield, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured recall (Z-1315-2012) | Qrs Diagnostic | 2012-03-23 |