FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
K Number: K850151
·
Decision Jul 19, 1985
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
10
Review Days
185
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Basic Information
- Device Name
- L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
- K Number
- K850151
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Life Products, Inc.
- Date Received
- January 15, 1985
- Decision Date
- July 19, 1985
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZO), ordered by most recent decision date.
UNICOR, INC. CORRUGATED TUBING
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PRIMA VENTILATOR HOSES
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PRIMA BREATHING BAGS
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PRIMA VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·Anesthesiology
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 |
| K851905 | LPA-2 REMOTE ALARM | Jul 8, 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 |