510(k) K040904
- Device
- PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
- Applicant
- PHILIPS MEDICAL SYSTEMS
- 510(k) number
- K040904
- Product code
- NSA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-09-16
- Date received
- 2004-04-07
- Regulation
- 870.5310
- Classification name
- Over-the-counter Automated External Defibrillator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 3
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERESA SKARR
- Address
- 2301 5th Ave., Suite 200 Seattle WA US 98121 98121
FDA Registration Numbers#
- 3004123209
- 1930027
- 3000126629
- 3012607778
- 3030677
- 3009077524
- 3011823740
- 3006108746
Source Documents#
Legacy Summary#
summary
FDA Review#
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