Respironics Bageasy Encor Adult Semi-Reusable
FDA 510(k) K934699 · Respironics, Inc.
510(k) numberK934699
Submission
- Device name
- Respironics Bageasy Encor Adult Semi-Reusable
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- September 30, 1993
- Decision date
- January 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5915
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Respironics Bageasy Encor Adult Semi-Reusable cleared by the FDA?
Respironics Bageasy Encor Adult Semi-Reusable (K934699) received a 510(k) decision of Substantially Equivalent on January 5, 1995, 462 days after the submission was received.
What is the product code of K934699?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.