Centurion-Ii, Model 3103 Apnea/Brady Cardia Trachy
FDA 510(k) K851889 · Clinical Data, Inc.
510(k) numberK851889
Submission
- Device name
- Centurion-Ii, Model 3103 Apnea/Brady Cardia Trachy
- Applicant
- Clinical Data, Inc.
Boston, MA, US - Received
- April 30, 1985
- Decision date
- October 23, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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Questions and answers
When was Centurion-Ii, Model 3103 Apnea/Brady Cardia Trachy cleared by the FDA?
Centurion-Ii, Model 3103 Apnea/Brady Cardia Trachy (K851889) received a 510(k) decision of Substantially Equivalent on October 23, 1985, 176 days after the submission was received.
What is the product code of K851889?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.