FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIFELINE IPPB SET-UP
K Number: K810341
·
Decision Mar 17, 1981
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
11
Review Days
35
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Basic Information
- Device Name
- LIFELINE IPPB SET-UP
- K Number
- K810341
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Todd Industries, Inc.
- Date Received
- February 10, 1981
- Decision Date
- March 17, 1981
- 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
FDA 510(k)
FDA Class 1
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UNICOR, INC. VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA CUSTOM ANESTESIA CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Todd Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K810343 | NEBULIZERS | Mar 17, 1981 | Substantially Equivalent |
| K810342 | NASAL CANNULA | Mar 17, 1981 | Substantially Equivalent |
| K810340 | ADULT MASKS & PEDIATRIC MASKS | Mar 17, 1981 | Substantially Equivalent |
| K810362 | CORRUGATED FLEX TUBING | Mar 17, 1981 | Substantially Equivalent |
| K810373 | VENTURI MASK/DELIVERY SYSTEM #'S | Mar 17, 1981 | Substantially Equivalent |
| K810361 | CONNECTOR ADAPTERS | Mar 17, 1981 | Substantially Equivalent |
| K810344 | OXYGEN TUBING | Mar 17, 1981 | Substantially Equivalent |
| K810339 | NOSECLIP #6118 | Mar 17, 1981 | Substantially Equivalent |
| K810430 | VENTURI MASK/DELIVERY SYSTEM #6078 | Mar 13, 1981 | Substantially Equivalent |
| K810374 | CORRUGATED FLEX TUBING #6000, | Mar 13, 1981 | Substantially Equivalent |