FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRENTWOOD EZ SCAN 200 AMBULATORY ECG
K Number: K842976
·
Decision Mar 1, 1985
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
21
Review Days
214
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Basic Information
- Device Name
- BRENTWOOD EZ SCAN 200 AMBULATORY ECG
- K Number
- K842976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Brentwood Instruments, Inc.
- Date Received
- July 30, 1984
- Decision Date
- March 1, 1985
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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Other Clearances by Brentwood Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896924 | SPIROSCAN 4000 | Mar 1, 1990 | Substantially Equivalent |
| K882366 | RHYTHMSCAN HR HOLTER RECORDER | Aug 2, 1988 | Substantially Equivalent |
| K871572 | RHYTHMSCAN | Feb 22, 1988 | Substantially Equivalent |
| K860024 | FUKUDA DENSHI CARDIMAX FCP-211 | Mar 31, 1986 | Substantially Equivalent |
| K853979 | CARDIMAX FX-1164 | Feb 6, 1986 | Substantially Equivalent |
| K854505 | CARDIMAX FX-406U | Feb 4, 1986 | Substantially Equivalent |
| K851135 | SPIRO SCAN | Jul 1, 1985 | Substantially Equivalent |
| K851124 | T-1000 ECG TRANSMITTER | May 15, 1985 | Substantially Equivalent |
| K851123 | R-1000 ECG RECEIVER | May 15, 1985 | Substantially Equivalent |
| K844470 | FUKUDA DENSHI MODEL FCP-220 | Jan 10, 1985 | Substantially Equivalent |