Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMNI~NEB; OMNI~MAX

K-Number: K030396 · 2004-05-07

ApplicantB&B Medical Technologies, Inc.
Decision Date2004-05-07
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OMNI~NEB; OMNI~MAX 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 2004-05-07 under 510(k) number K030396. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI~NEB; OMNI~MAX?

OMNI~NEB; OMNI~MAX is a medical device that received FDA 510(k) clearance on 2004-05-07. The listed applicant is B&B Medical Technologies, Inc.. The 510(k) number is K030396.

When did OMNI~NEB; OMNI~MAX receive FDA 510(k) clearance?

OMNI~NEB; OMNI~MAX received FDA 510(k) clearance on 2004-05-07, under 510(k) number K030396.

Who is the listed applicant for OMNI~NEB; OMNI~MAX?

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 OMNI~NEB; OMNI~MAX?

The FDA product code for OMNI~NEB; OMNI~MAX is CAF.

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

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.

K980407HOPE NEBULIZERK960663UNIVERSAL BITE BLOCKK945816QUICK-LOCKK944324SURE-LOCK VENTILATOR TUBING HOLDERK935171STABILTRACHK925386ADHESIVE E.T. TAPE

View all 23 devices →

Related Devices (Code: CAF)

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.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

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.

↑