FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AS 1740 INTERFACE MODULE
K Number: K831428
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
334
Applicant Total
30
Review Days
164
Basic Information
- Device Name
- AS 1740 INTERFACE MODULE
- K Number
- K831428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- NARCO SCIENTIFIC
- Date Received
- May 3, 1983
- Decision Date
- October 14, 1983
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRT), ordered by most recent decision date.
The Circadia C200 System
FDA 510(k)
FDA Class 2
·Cardiovascular
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
FDA 510(k)
FDA Class 2
·Cardiovascular
Neteera 130H-Plus Vital Sign Monitoring Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+
FDA 510(k)
FDA Class 2
·Cardiovascular
Neteera 130H/131H Vital Sign Monitoring Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
Cardiac Trigger Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by NARCO SCIENTIFIC
| K Number | Device Name | ||
|---|---|---|---|
| K830338 | NARCOTRACE 80 | Dec 22, 1983 | Substantially Equivalent |
| K831429 | AS 191 ECG TELEMETRY MODULE | Oct 14, 1983 | Substantially Equivalent |
| K822835 | PZ-800 VOLUME VENTILATOR | Sep 29, 1983 | Substantially Equivalent |
| K831430 | AIR SHIELDS AS-100 MONIORING SYS-AS105 | Sep 12, 1983 | Substantially Equivalent |
| K831460 | AS 30/TCP MODULE | Jul 12, 1983 | Substantially Equivalent |
| K830123 | DISP. YANKAVER SURG. SUCTION INSTRUMENT | Jun 8, 1983 | Substantially Equivalent |
| K831028 | TI-1000 TRANSPORT INCUBATOR | May 9, 1983 | Substantially Equivalent |
| K823899 | INFANT CARE SYSTEM | Apr 14, 1983 | Substantially Equivalent |
| K830680 | AIR-SHIELDS VENTIMETER VENTILATOR-CONTR | Apr 8, 1983 | Substantially Equivalent |
| K830654 | INFUSION PUMP RETROGRADE EXTEN. AS 715 | Mar 24, 1983 | Substantially Equivalent |