PATIENT ALERT MODEL 555— 510(k) K772350
Substantially EquivalentIntermedics, Inc.
FDA 510(k) clearance K772350 for PATIENT ALERT MODEL 555, Substantially Equivalent on 1978-03-09. Applicant: Intermedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Intermedics, Inc.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.