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FDA 510(k)

BODAI NEO2-SAFE(TM)

K-Number: K873696 · 1988-04-14

ApplicantB&B Medical Technologies, Inc.
Decision Date1988-04-14
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BODAI NEO2-SAFE(TM) 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 1988-04-14 under 510(k) number K873696. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODAI NEO2-SAFE(TM)?

BODAI NEO2-SAFE(TM) is a medical device that received FDA 510(k) clearance on 1988-04-14. The listed applicant is B&B Medical Technologies, Inc.. The 510(k) number is K873696.

When did BODAI NEO2-SAFE(TM) receive FDA 510(k) clearance?

BODAI NEO2-SAFE(TM) received FDA 510(k) clearance on 1988-04-14, under 510(k) number K873696.

Who is the listed applicant for BODAI NEO2-SAFE(TM)?

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(TM)?

The FDA product code for BODAI NEO2-SAFE(TM) is BZA.

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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.

K030396OMNI~NEB; OMNI~MAXK980407HOPE NEBULIZERK960663UNIVERSAL BITE BLOCKK945816QUICK-LOCKK944324SURE-LOCK VENTILATOR TUBING HOLDERK935171STABILTRACH

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Related Devices (Code: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, 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.

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