FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LPA-2 REMOTE ALARM
K Number: K851905
·
Decision Jul 8, 1985
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
10
Review Days
69
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Basic Information
- Device Name
- LPA-2 REMOTE ALARM
- K Number
- K851905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Life Products, Inc.
- Date Received
- April 30, 1985
- Decision Date
- July 8, 1985
- Product Code
- CAP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | FDA class 2 | Anesthesiology |
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Other Clearances by Life Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901714 | LIFESTYLE HOME TANNING UNITS | Jun 27, 1990 | Substantially Equivalent |
| K854022 | LPA-1 PRESSURE MONITOR | Dec 24, 1985 | Substantially Equivalent |
| K850151 | L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT | Jul 19, 1985 | Substantially Equivalent |
| K851805 | LPA-3 PRINTER | Jul 8, 1985 | Substantially Equivalent |
| K842122 | 4A | Jan 18, 1985 | Substantially Equivalent |
| K844179 | LP-5 | Jan 18, 1985 | Substantially Equivalent |
| K844081 | LP4 VENTILATOR | Jan 16, 1985 | Substantially Equivalent |
| K844290 | L100D PATIENT CIRCUIT DUAL LINE | Jan 10, 1985 | Substantially Equivalent |
| K770132 | MODEL LP-3 PORTABLE VOLUME VENTILATOR | Feb 1, 1977 | Substantially Equivalent |