Respironics Venteasy
FDA 510(k) K842693 · Respironics, Inc.
510(k) numberK842693
Submission
- Device name
- Respironics Venteasy
- Applicant
- Respironics, Inc.
Monroeville, PA, US - Received
- July 11, 1984
- Decision date
- August 10, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated | Ambu A/S | 08/29/2016SE |
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Questions and answers
When was Respironics Venteasy cleared by the FDA?
Respironics Venteasy (K842693) received a 510(k) decision of Substantially Equivalent on August 10, 1984, 30 days after the submission was received.
What is the product code of K842693?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.