FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
HEARTSTART 911
K Number: K954609
·
Decision Jan 4, 1996
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
11
Review Days
92
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Basic Information
- Device Name
- HEARTSTART 911
- K Number
- K954609
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laerdal Medical Corp.
- Date Received
- October 4, 1995
- Decision Date
- January 4, 1996
- Product Code
- MKJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | Cardiovascular |
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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 |
| 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 |
| 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 |