FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NARCOTRACE 40 - NT40
K Number: K833656
·
Decision May 9, 1984
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
9
Review Days
202
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Basic Information
- Device Name
- NARCOTRACE 40 - NT40
- K Number
- K833656
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Narco Bio-Systems
- Date Received
- October 20, 1983
- Decision Date
- May 9, 1984
- Product Code
- DSF
- 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 |
|---|---|---|---|
| DSF | Recorder, Paper Chart | FDA class 1 | Cardiovascular |
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Other Clearances by Narco Bio-Systems
| K Number | Device Name | ||
|---|---|---|---|
| K853683 | UMS-100 | Jan 10, 1986 | Substantially Equivalent |
| K832869 | MOTILITY MEASUREMENT SYS MMS-100 | Oct 31, 1983 | Substantially Equivalent |
| K813502 | NARCO TELECARE ISOFLO PRESSURE MONITOR | Dec 29, 1981 | Substantially Equivalent |
| K811376 | ULTRASONIC QFM SYSTEM 1000 | Aug 13, 1981 | Substantially Equivalent |
| K810431 | NARCO TLECARE MINIATURE PRESSURE DOME | Mar 11, 1981 | Substantially Equivalent |
| K801544 | PORTA-FIB LPD | Jul 14, 1980 | Substantially Equivalent |
| K760084 | MONITOR, GSR (NB-401) | Jul 26, 1976 | Substantially Equivalent |
| K760083 | PHYSIOSCOPE | Jul 20, 1976 | Substantially Equivalent |