Berman Airway
FDA 510(k) K936134 · Smiths Industries Medical Systems, Inc.
510(k) numberK936134
Submission
- Device name
- Berman Airway
- Applicant
- Smiths Industries Medical Systems, Inc.
Keene, NH, US - Received
- December 23, 1993
- Decision date
- January 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAE – Airway, Oropharyngeal, Anesthesiology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5110
- Specialty
- Anesthesiology
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Questions and answers
When was Berman Airway cleared by the FDA?
Berman Airway (K936134) received a 510(k) decision of Substantially Equivalent on January 28, 1994, 36 days after the submission was received.
What is the product code of K936134?
The FDA product code is CAE – Airway, Oropharyngeal, Anesthesiology, a Class I (low risk) device regulated under 21 CFR 868.5110.