Auto-Peep Measurement Device, Model # KC 9-P
FDA 510(k) K983631 · Instrumentation Industries, Inc.
510(k) numberK983631
Submission
- Device name
- Auto-Peep Measurement Device, Model # KC 9-P
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- October 15, 1998
- Decision date
- July 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBP – Valve, Non-Rebreathing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5870
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Auto-Peep Measurement Device, Model # KC 9-P cleared by the FDA?
Auto-Peep Measurement Device, Model # KC 9-P (K983631) received a 510(k) decision of Substantially Equivalent on July 1, 1999, 259 days after the submission was received.
What is the product code of K983631?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.