FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BR-50-J DISPOSABLE ECG ELECTRODE
K Number: K921579
·
Decision May 26, 1992
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
14
Review Days
54
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Basic Information
- Device Name
- BR-50-J DISPOSABLE ECG ELECTRODE
- K Number
- K921579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medicotest, Inc.
- Date Received
- April 2, 1992
- Decision Date
- May 26, 1992
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Medicotest, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983597 | NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES | Jan 11, 1999 | Substantially Equivalent |
| K970639 | NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K | May 15, 1997 | Substantially Equivalent |
| K961643 | MEDICOTEST ECG ELECTRODES | Dec 9, 1996 | Substantially Equivalent |
| K952176 | DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K | Sep 25, 1995 | Substantially Equivalent |
| K941568 | K-10-VS, DA-05-VS, RECORDING ELECTRODES | Nov 4, 1994 | Substantially Equivalent |
| K931426 | NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE | Dec 21, 1993 | Substantially Equivalent |
| K931430 | CUTANEOUS ELECTRODE | Dec 21, 1993 | Substantially Equivalent |
| K926264 | MEDICOTEST SKIN FIX | Apr 20, 1993 | Substantially Equivalent |
| K914672 | QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE | Oct 31, 1991 | Substantially Equivalent |
| K902407 | NF-50-E DISPOSABLE ECG ELECTRODE | Jul 31, 1990 | Substantially Equivalent |