FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAERDAL POCKET MASK
K Number: K861401
·
Decision May 21, 1986
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
11
Review Days
36
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
- LAERDAL POCKET MASK
- K Number
- K861401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Laerdal Medical Corp.
- Date Received
- April 15, 1986
- Decision Date
- May 21, 1986
- Product Code
- CBP
- 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBP), ordered by most recent decision date.
QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
FDA 510(k)
FDA Class 2
·Anesthesiology
F&P Optiflow Flow Diverter
FDA 510(k)
FDA Class 2
·Anesthesiology
Altech® Exhalation Valve (Single Limb and Dual Limb)
FDA 510(k)
FDA Class 2
·Anesthesiology
CPR Face Shield
FDA 510(k)
FDA Class 2
·Anesthesiology
OJR215 Pressure Relief Manifold
FDA 510(k)
FDA Class 2
·Anesthesiology
Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Laerdal Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001742 | RESUSCI INFLATE-A-SHIELD CPR BARRIER | Oct 6, 2000 | Substantially Equivalent |
| K962361 | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | Sep 5, 1996 | Substantially Equivalent |
| K954771 | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) | May 9, 1996 | Substantially Equivalent |
| K954609 | HEARTSTART 911 | Jan 4, 1996 | Substantially Equivalent |
| K950698 | LSU 2000 PORTABLE SUCTION UNIT | May 9, 1995 | Substantially Equivalent |
| K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | Dec 2, 1993 | Substantially Equivalent |
| K896919 | HEARTSTART 3000 | May 3, 1990 | Substantially Equivalent |
| K880450 | RESUSCI PATIENT FACE SHIELD | Mar 4, 1988 | Substantially Equivalent |
| K840110 | LAERDAL SUCTION UNIT | Mar 12, 1984 | Substantially Equivalent |
| K822356 | MODULAIDE EMERG. CARDIAC LIFE SUPP. KT | Aug 20, 1982 | Substantially Equivalent |