FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
K Number: K991871
·
Decision Aug 5, 1999
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
230
Review Days
65
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Basic Information
- Device Name
- HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
- K Number
- K991871
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hewlett-Packard Co.
- Date Received
- June 1, 1999
- Decision Date
- August 5, 1999
- 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 Hewlett-Packard Co.
| K Number | Device Name | ||
|---|---|---|---|
| K992543 | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE | May 18, 2000 | Substantially Equivalent |
| K993587 | HP M2376A DEVICE LINK SYSTEM | Jan 20, 2000 | Substantially Equivalent |
| K993169 | MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A | Dec 20, 1999 | Substantially Equivalent |
| K992977 | HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A | Dec 1, 1999 | Substantially Equivalent |
| K993516 | HP M2600A VIRIDIA TELEMETRY SYSTEM | Nov 8, 1999 | Substantially Equivalent |
| K993171 | HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A | Oct 21, 1999 | Substantially Equivalent |
| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A | Aug 31, 1999 | Substantially Equivalent |
| K984194 | HP M2376A DEVICE LINK SYSTEM | Apr 30, 1999 | Substantially Equivalent |
| K990400 | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM | Feb 24, 1999 | Substantially Equivalent |
| K990339 | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O | Feb 18, 1999 | Substantially Equivalent |