Thermique
FDA 510(k) K022097 · Parkell, Inc.
510(k) numberK022097
Submission
- Device name
- Thermique
- Applicant
- Parkell, Inc.
Farmingdale, NY, US - Received
- June 27, 2002
- Decision date
- September 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Thermique cleared by the FDA?
Thermique (K022097) received a 510(k) decision of Substantially Equivalent on September 6, 2002, 71 days after the submission was received.
What is the product code of K022097?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.