FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTERNAL VALVE FUNCTION BLOCK
K Number: K830914
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
69
Review Days
141
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Basic Information
- Device Name
- EXTERNAL VALVE FUNCTION BLOCK
- K Number
- K830914
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2060
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Honeywell, Inc.
- Date Received
- March 24, 1983
- Decision Date
- August 12, 1983
- Product Code
- DRQ
- 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 |
|---|---|---|---|
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | FDA class 2 | Cardiovascular |
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Other Clearances by Honeywell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902230 | COLORADO COLOR IMAGING RECORDER | Jun 19, 1990 | Substantially Equivalent |
| K863100 | CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR | Feb 3, 1987 | Substantially Equivalent |
| K853501 | HONEYWELL ELECTRONIC VENTILATOR EV-A | Apr 4, 1986 | Substantially Equivalent |
| K855125 | PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM | Mar 26, 1986 | Substantially Equivalent |
| K851888 | APM DISPOS. BLOOD PRESSURE TRANSDUCER | Aug 6, 1985 | Substantially Equivalent |
| K851496 | ECG MONITOR MODEL RM102 | Jul 24, 1985 | Substantially Equivalent |
| K850794 | PATIENT MONITOR MODEL RM-300 | Apr 18, 1985 | Substantially Equivalent |
| K851092 | PORTABLE DEFIBRILLATOR/MONITOR ED 425 | Apr 10, 1985 | Substantially Equivalent |
| K834530 | EXTENSION BOX EB200 | Jun 1, 1984 | Substantially Equivalent |
| K834282 | ULTRA IMAGER 2000 | Apr 23, 1984 | Substantially Equivalent |