FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFE WATCH LSI
K Number: K822615
·
Decision Sep 21, 1982
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
20
Review Days
22
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Basic Information
- Device Name
- LIFE WATCH LSI
- K Number
- K822615
- 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 30, 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 |
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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 |
| K822389 | LIFE TRACE 40/42 | Sep 21, 1982 | Substantially Equivalent |
| K822294 | VPD-261 DEFIBRILLATOR MONITOR | Aug 31, 1982 | Substantially Equivalent |