TEMPERATURE CONTROLLER MODEL 17000— 510(k) K781530
Substantially EquivalentHealthdyne, Inc.
FDA 510(k) clearance K781530 for TEMPERATURE CONTROLLER MODEL 17000, Substantially Equivalent on 1978-11-14. Applicant: Healthdyne, Inc.. Device class: 2.
Clearance details
- Applicant
- Healthdyne, Inc.
- Product code
- Code BZE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5270
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Healthdyne, Inc.
view allAdverse events under product code BZE
product code BZE- Death
- 4
- Malfunction
- 910
- Other
- 1
- Total
- 915
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.