FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENT SELECTOR FUNCTION BLOCK
K Number: K832212
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
69
Review Days
100
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PATIENT SELECTOR FUNCTION BLOCK
- K Number
- K832212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Honeywell, Inc.
- Date Received
- July 6, 1983
- Decision Date
- October 14, 1983
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPS), ordered by most recent decision date.
MAC 7 Resting ECG Analysis System
FDA 510(k)
FDA Class 2
·Cardiovascular
AccurECG Analysis System (v2.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
Withings BeamO (SCT02)
FDA 510(k)
FDA Class 2
·Cardiovascular
Cardiologs Holter Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
ZBPro Diagnostic
FDA 510(k)
FDA Class 2
·Cardiovascular
Masimo W1
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |