FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LAERDAL(TM) POCKET MASK, MODIFICATION
K Number: K933048
·
Decision Dec 2, 1993
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
12
Applicant Total
11
Review Days
205
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Basic Information
- Device Name
- LAERDAL(TM) POCKET MASK, MODIFICATION
- K Number
- K933048
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5570
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Laerdal Medical Corp.
- Date Received
- May 11, 1993
- Decision Date
- December 2, 1993
- Product Code
- KGB
- 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 |
|---|---|---|---|
| KGB | Mask, Oxygen, Non-Rebreathing | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGB), ordered by most recent decision date.
POCKET RESCUE
FDA 510(k)
FDA Class 1
·Anesthesiology
ULTIMATE SEAL
FDA 510(k)
FDA Class 1
·Anesthesiology
COMBO MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·Anesthesiology
COMPACT MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
NONREBREATHING VALVE
FDA 510(k)
FDA Class 1
·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 |
| K896919 | HEARTSTART 3000 | May 3, 1990 | Substantially Equivalent |
| K880450 | RESUSCI PATIENT FACE SHIELD | Mar 4, 1988 | Substantially Equivalent |
| K861401 | LAERDAL POCKET MASK | May 21, 1986 | Substantially Equivalent |
| K840110 | LAERDAL SUCTION UNIT | Mar 12, 1984 | Substantially Equivalent |
| K822356 | MODULAIDE EMERG. CARDIAC LIFE SUPP. KT | Aug 20, 1982 | Substantially Equivalent |