Digital Cuff PV Gauge
FDA 510(k) K900755 · International Medical Products, Inc.
510(k) numberK900755
Submission
- Device name
- Digital Cuff PV Gauge
- Applicant
- International Medical Products, Inc.
Mentor, OH, US - Received
- February 16, 1990
- Decision date
- April 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSK – Cuff, Tracheal Tube, Inflatable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5750
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Digital Cuff PV Gauge cleared by the FDA?
Digital Cuff PV Gauge (K900755) received a 510(k) decision of Substantially Equivalent on April 26, 1990, 69 days after the submission was received.
What is the product code of K900755?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.