FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K Number: K002280
·
Decision Feb 5, 2001
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
49
Review Days
194
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
- PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
- K Number
- K002280
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Devices, Inc.
- Date Received
- July 26, 2000
- Decision Date
- February 5, 2001
- 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
Other Clearances by Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930084 | MICRO-ARTHROSCOPE | Sep 1, 1995 | Substantially Equivalent for Some Indications |
| K943126 | ELECTROFLEX | Dec 5, 1994 | Substantially Equivalent |
| K940012 | SMARTBRACE ELECTRODE | Dec 5, 1994 | Substantially Equivalent |
| K935132 | HOME MICROCURRENT HMC | Mar 14, 1994 | Substantially Equivalent |
| K934619 | FLEXMATE | Feb 23, 1994 | Substantially Equivalent |
| K924897 | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 | Jul 6, 1993 | Substantially Equivalent |
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | May 17, 1993 | Substantially Equivalent |
| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | Jul 21, 1992 | Substantially Equivalent |
| K915694 | MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR | Jun 18, 1992 | Substantially Equivalent |