Respiratory Sensor
FDA 510(k) K811014 · Impact Instrumentation, Inc.
510(k) numberK811014
Submission
- Device name
- Respiratory Sensor
- Applicant
- Impact Instrumentation, Inc.
Mchenry, IL, US - Received
- April 15, 1981
- Decision date
- June 2, 1981
- 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 Respiratory Sensor cleared by the FDA?
Respiratory Sensor (K811014) received a 510(k) decision of Substantially Equivalent on June 2, 1981, 48 days after the submission was received.
What is the product code of K811014?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.