FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHYTHMSCAN HR HOLTER RECORDER
K Number: K882366
·
Decision Aug 2, 1988
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
190
Applicant Total
21
Review Days
55
Basic Information
- Device Name
- RHYTHMSCAN HR HOLTER RECORDER
- K Number
- K882366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- BRENTWOOD INSTRUMENTS, INC.
- Date Received
- June 8, 1988
- Decision Date
- August 2, 1988
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 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 |
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| K860024 | FUKUDA DENSHI CARDIMAX FCP-211 | Mar 31, 1986 | Substantially Equivalent |
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| K851124 | T-1000 ECG TRANSMITTER | May 15, 1985 | Substantially Equivalent |
| K851123 | R-1000 ECG RECEIVER | May 15, 1985 | Substantially Equivalent |
| K842976 | BRENTWOOD EZ SCAN 200 AMBULATORY ECG | Mar 1, 1985 | Substantially Equivalent |
| K844470 | FUKUDA DENSHI MODEL FCP-220 | Jan 10, 1985 | Substantially Equivalent |