FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
SMARTLANK WIRELESS, MODEL 001970
K Number: K033642
·
Decision May 25, 2004
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
1
Review Days
187
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
- SMARTLANK WIRELESS, MODEL 001970
- K Number
- K033642
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mrl, A Welch Allyn Company
- Date Received
- November 20, 2003
- Decision Date
- May 25, 2004
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MKJ), ordered by most recent decision date.
Powerheart G5 AED
FDA 510(k)
FDA Class 3
·Cardiovascular
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
FDA 510(k)
FDA Class 3
·Cardiovascular
OneStep Pediatric CPR Multi-Function Electrode
FDA 510(k)
FDA Class 3
·Cardiovascular
samaritan PAD 450P
FDA 510(k)
FDA Class 3
·Cardiovascular
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
FDA 510(k)
FDA Class 3
·Cardiovascular
ZOLL E SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular