Regulator, Pressure, Expiratory
FDA 510(k) K770766 · Globe Safety Products, Inc.
510(k) numberK770766
Submission
- Device name
- Regulator, Pressure, Expiratory
- Applicant
- Globe Safety Products, Inc.
Mchenry, IL, US - Received
- April 28, 1977
- Decision date
- May 10, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional | Draeger Medical AG & Co. KG | 08/06/2010SE |
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Questions and answers
When was Regulator, Pressure, Expiratory cleared by the FDA?
Regulator, Pressure, Expiratory (K770766) received a 510(k) decision of Substantially Equivalent on May 10, 1977, 12 days after the submission was received.
What is the product code of K770766?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.