Ultima Airflow Sensor, 0510
FDA 510(k) K981445 · Braebon Medical Corp.
510(k) numberK981445
Submission
- Device name
- Ultima Airflow Sensor, 0510
- Applicant
- Braebon Medical Corp.
Kanata, CA - Received
- April 22, 1998
- Decision date
- October 5, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Ultima Airflow Sensor, 0510 cleared by the FDA?
Ultima Airflow Sensor, 0510 (K981445) received a 510(k) decision of Substantially Equivalent on October 5, 1998, 166 days after the submission was received.
What is the product code of K981445?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.