FDA 510(k)
Substantially Equivalent
🇺🇸 United States
STRESS/EMERGENCY EELCTRODE
K Number: K790883
·
Decision Jul 24, 1979
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
76
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Basic Information
- Device Name
- STRESS/EMERGENCY EELCTRODE
- K Number
- K790883
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Hayes Products, Inc.
- Date Received
- May 9, 1979
- Decision Date
- July 24, 1979
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- Third Party
- N
Other Clearances by Hayes Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791140 | PREGELLED DISPOSABLE EELCTRO. SERIES 600 | Jul 10, 1979 | Substantially Equivalent |
| K791139 | PREGELLED DISPOSABLE ECG ELECTRODES | Jul 10, 1979 | Substantially Equivalent |
| K781940 | EKG ELECTRODES, DISPOSABLE | Nov 29, 1978 | Substantially Equivalent |
| K771447 | PREGELLED DISP. EKG MONITORING ELECT- | Aug 4, 1977 | Substantially Equivalent |