Atlas FDA

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

RecordFirmDate
QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured recall (Z-1315-2012)Qrs Diagnostic2012-03-23