Clinical Data Apnea Detector
FDA 510(k) K821721 · Clinical Data, Inc.
510(k) numberK821721
Submission
- Device name
- Clinical Data Apnea Detector
- Applicant
- Clinical Data, Inc.
Mchenry, IL, US - Received
- June 10, 1982
- Decision date
- July 13, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLS – Monitor, Apnea, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2377
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Clinical Data Apnea Detector cleared by the FDA?
Clinical Data Apnea Detector (K821721) received a 510(k) decision of Substantially Equivalent on July 13, 1982, 33 days after the submission was received.
What is the product code of K821721?
The FDA product code is FLS – Monitor, Apnea, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.2377.