Device Classification Name |
monitor, cardiac (incl. cardiotachometer & rate alarm) |
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---|---|---|---|---|
510(k) Number | K992413 | |||
Device Name | ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR | |||
Applicant |
|
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Applicant Contact | david m trueblood | |||
Correspondent |
|
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Correspodent Contact | david m trueblood | |||
Regulation Number | 870.2300 | |||
Classification Product Code |
|
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Subsequent Product Codes |
|
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Date Received | 07/20/1999 | |||
Decision Date | 08/19/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
Cardiovascular |
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summary |
summary |
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Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |