Edentec Model 2860 Pressure Meter
FDA 510(k) K891540 · Edentec Corp.
510(k) numberK891540
Submission
- Device name
- Edentec Model 2860 Pressure Meter
- Applicant
- Edentec Corp.
Eden Prairie, MN, US - Received
- March 17, 1989
- Decision date
- June 1, 1989
- 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 Edentec Model 2860 Pressure Meter cleared by the FDA?
Edentec Model 2860 Pressure Meter (K891540) received a 510(k) decision of Substantially Equivalent on June 1, 1989, 76 days after the submission was received.
What is the product code of K891540?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.