Tek-Pro Tek-Tator V Rotator & Humidify
FDA 510(k) K820043 · American Dade
510(k) numberK820043
Submission
- Device name
- Tek-Pro Tek-Tator V Rotator & Humidify
- Applicant
- American Dade
Mchenry, IL, US - Received
- January 7, 1982
- Decision date
- January 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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Questions and answers
When was Tek-Pro Tek-Tator V Rotator & Humidify cleared by the FDA?
Tek-Pro Tek-Tator V Rotator & Humidify (K820043) received a 510(k) decision of Substantially Equivalent on January 28, 1982, 21 days after the submission was received.
What is the product code of K820043?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.