INFANT MONITOR— 510(k) K820645
Substantially EquivalentHealthdyne, Inc.
FDA 510(k) clearance K820645 for INFANT MONITOR, Substantially Equivalent on 1982-04-15. Applicant: Healthdyne, Inc.. Device class: 2.
Clearance details
- Applicant
- Healthdyne, Inc.
- Product code
- Code BZQ
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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