FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESUSCI PATIENT FACE SHIELD
K Number: K880450
·
Decision Mar 4, 1988
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
11
Review Days
31
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Basic Information
- Device Name
- RESUSCI PATIENT FACE SHIELD
- K Number
- K880450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Laerdal Medical Corp.
- Date Received
- February 2, 1988
- Decision Date
- March 4, 1988
- Product Code
- BTM
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by Laerdal Medical Corp.
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|---|---|---|---|
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| 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 |
| 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 |