FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFE TRACE 40/42
K Number: K822389
·
Decision Sep 21, 1982
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
20
Review Days
43
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
- LIFE TRACE 40/42
- K Number
- K822389
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Life Science Instrumentation, Inc.
- Date Received
- August 9, 1982
- Decision Date
- September 21, 1982
- 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 C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+ (Model 2.5)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+ (2.5)
FDA 510(k)
FDA Class 2
·Cardiovascular
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
Other Clearances by Life Science Instrumentation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850812 | EMERGIPACE - EXTERNAL PACEMAKER | Nov 5, 1985 | Substantially Equivalent |
| K842037 | LS 5 | Mar 1, 1985 | Substantially Equivalent |
| K843396 | LS-260G MONITOR/RECORDER & DEFIBILLATOR | Oct 19, 1984 | Substantially Equivalent |
| K840246 | MINI-DEFIBRILLATOR 280/4 | Apr 17, 1984 | Substantially Equivalent |
| K831056 | DEFIBRILLATOR VPD 545 | Apr 28, 1983 | Substantially Equivalent |
| K822617 | VPD540 DEFIBRILLATOR | Apr 28, 1983 | Substantially Equivalent |
| K822616 | LS6 ARRYTHMIA DISCRIMINATOR | Oct 18, 1982 | Substantially Equivalent |
| K822390 | LIFE TRACE 24 | Sep 21, 1982 | Substantially Equivalent |
| K822615 | LIFE WATCH LSI | Sep 21, 1982 | Substantially Equivalent |
| K822294 | VPD-261 DEFIBRILLATOR MONITOR | Aug 31, 1982 | Substantially Equivalent |