FDA 510(k)
Unknown
🇺🇸 United States
FCP-11ECG
K Number: K842169
·
Decision Mar 13, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
21
Review Days
—
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Basic Information
- Device Name
- FCP-11ECG
- K Number
- K842169
- Clearance Type
- Traditional
- Decision
- Unknown
- Applicant
- Brentwood Instruments, Inc.
- Date Received
- March 13, 1984
- Decision Date
- March 13, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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 |
| K842976 | BRENTWOOD EZ SCAN 200 AMBULATORY ECG | Mar 1, 1985 | Substantially Equivalent |