Montgomery Tracheostomy Speaking Valve
FDA 510(k) K955634 · Boston Medical Products, Inc.
510(k) numberK955634
Submission
- Device name
- Montgomery Tracheostomy Speaking Valve
- Applicant
- Boston Medical Products, Inc.
Westborough, MA, US - Received
- December 11, 1995
- Decision date
- June 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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More from Intersurgical Incorporated
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| K091135 | Rutter Supra Stomal StentsFWN · Traditional | 09/14/2009SE |
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| K972459 | Rhinocell Nasal PackingsEMX · Traditional | 08/04/1997SE |
| K972096 | Bivalve Nasal SplintLYA · Traditional | 07/15/1997SE |
| K972078 | Post-Stop Epistaxis CatheterEMX · Traditional | 07/10/1997SE |
| K972092 | Nasal Airway SplintLYA · Traditional | 07/08/1997SE |
| K972151 | Doyle Combo Nasal Airway SplintLYA · Traditional | 07/07/1997SE |
| K972082 | Custom Nasal SplintLYA · Traditional | 07/03/1997SE |
| K972060 | Nasal Septal ButtonLFB · Traditional | 07/03/1997SE |
| K972077 | Epi-Stop Epistaxis CatheterEMX · Traditional | 06/26/1997SE |
Questions and answers
When was Montgomery Tracheostomy Speaking Valve cleared by the FDA?
Montgomery Tracheostomy Speaking Valve (K955634) received a 510(k) decision of Substantially Equivalent on June 10, 1996, 182 days after the submission was received.
What is the product code of K955634?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.