FDA 510(k)

BODAI NEO2 -SAFE AIRWAY PRESSURE CAP

K-Number: K913753 · 1991-10-23

Decision Date1991-10-23

Product CodeCAI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BODAI NEO2 -SAFE AIRWAY PRESSURE CAP is the device name listed in this FDA 510(k) record. The listed applicant is B&B Medical Technologies, Inc.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K913753. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODAI NEO2 -SAFE AIRWAY PRESSURE CAP?

BODAI NEO2 -SAFE AIRWAY PRESSURE CAP is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is B&B Medical Technologies, Inc.. The 510(k) number is K913753.

When did BODAI NEO2 -SAFE AIRWAY PRESSURE CAP receive FDA 510(k) clearance?

BODAI NEO2 -SAFE AIRWAY PRESSURE CAP received FDA 510(k) clearance on 1991-10-23, under 510(k) number K913753.

Who is the listed applicant for BODAI NEO2 -SAFE AIRWAY PRESSURE CAP?

The FDA 510(k) record lists B&B Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BODAI NEO2 -SAFE AIRWAY PRESSURE CAP?

The FDA product code for BODAI NEO2 -SAFE AIRWAY PRESSURE CAP is CAI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing B&B Medical Technologies, Inc. as applicant

K030396OMNI~NEB; OMNI~MAX K980407HOPE NEBULIZER K960663UNIVERSAL BITE BLOCK K945816QUICK-LOCK K944324SURE-LOCK VENTILATOR TUBING HOLDER K935171STABILTRACH

View all 23 devices →

Related Devices (Code: CAI)

K954480CONDENSATE COLLECTION KITNova-Ventrx K953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.