Respiratory Sensor (Model 409 W/Nasoph.)
FDA 510(k) K811265 · Impact Instrumentation, Inc.
510(k) numberK811265
Submission
- Device name
- Respiratory Sensor (Model 409 W/Nasoph.)
- Applicant
- Impact Instrumentation, Inc.
Walker, MI, US - Received
- May 12, 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 (Model 409 W/Nasoph.) cleared by the FDA?
Respiratory Sensor (Model 409 W/Nasoph.) (K811265) received a 510(k) decision of Substantially Equivalent on June 2, 1981, 21 days after the submission was received.
What is the product code of K811265?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.