Modified Ohmeda Peep Valve (for GMS Absorber)
FDA 510(k) K881614 · Ohmeda Medical
510(k) numberK881614
Submission
- Device name
- Modified Ohmeda Peep Valve (for GMS Absorber)
- Applicant
- Ohmeda Medical
Madison, WI, US - Received
- April 12, 1988
- Decision date
- April 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Modified Ohmeda Peep Valve (for GMS Absorber) cleared by the FDA?
Modified Ohmeda Peep Valve (for GMS Absorber) (K881614) received a 510(k) decision of Substantially Equivalent on April 29, 1988, 17 days after the submission was received.
What is the product code of K881614?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.