FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ES 1500 ECG DEMODULATOR
K Number: K921699
·
Decision Dec 17, 1992
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
292
Applicant Total
3
Review Days
253
Basic Information
- Device Name
- ES 1500 ECG DEMODULATOR
- K Number
- K921699
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- EPIC SYSTEMS, INC.
- Date Received
- April 8, 1992
- Decision Date
- December 17, 1992
- Product Code
- DXH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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