FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
K Number: K071391
·
Decision Sep 7, 2007
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
113
Applicant Total
111
Review Days
112
Basic Information
- Device Name
- PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
- K Number
- K071391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHILIPS MEDICAL SYSTEMS, INC.
- Date Received
- May 18, 2007
- Decision Date
- September 7, 2007
- Product Code
- MSX
- 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 |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
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