Bodai NEO2 -Safe Airway Pressure Cap
FDA 510(k) K913753 · B&B Medical Technologies, Inc.
510(k) numberK913753
Submission
- Device name
- Bodai NEO2 -Safe Airway Pressure Cap
- Applicant
- B&B Medical Technologies, Inc.
Orangevale, CA, US - Received
- August 21, 1991
- Decision date
- October 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAI – Circuit, Breathing (W Connector, Adaptor, Y Piece)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5240
- Specialty
- Anesthesiology
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Questions and answers
When was Bodai NEO2 -Safe Airway Pressure Cap cleared by the FDA?
Bodai NEO2 -Safe Airway Pressure Cap (K913753) received a 510(k) decision of Substantially Equivalent on October 23, 1991, 63 days after the submission was received.
What is the product code of K913753?
The FDA product code is CAI – Circuit, Breathing (W Connector, Adaptor, Y Piece), a Class I (low risk) device regulated under 21 CFR 868.5240.