510(k) K945511
- Device
- LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
- Applicant
- PHYSIO-CONTROL CORP.
- 510(k) number
- K945511
- Product code
- MPE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-09-26
- Date received
- 1994-11-09
- Regulation
- 870.5550
- Classification name
- Auxiliary Power Supply (acor Dc) For External Transcutaneous Cardiac Pacemaker
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL D WILLINGHAM
- Address
- 11811 Willows Rd., NE P.O. Box 97006 Redmond WA US 98073 98073
Source Documents#
Legacy Summary#
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FDA Review#
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