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FDA 510(k)

OXY-OFF(TM)

K-Number: K863510 · 1986-10-22

ApplicantB&B Medical Technologies, Inc.
Decision Date1986-10-22
Product CodeBXY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXY-OFF(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 1986-10-22 under 510(k) number K863510. The device is classified under product code BXY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXY-OFF(TM)?

OXY-OFF(TM) is a medical device that received FDA 510(k) clearance on 1986-10-22. The listed applicant is B&B Medical Technologies, Inc.. The 510(k) number is K863510.

When did OXY-OFF(TM) receive FDA 510(k) clearance?

OXY-OFF(TM) received FDA 510(k) clearance on 1986-10-22, under 510(k) number K863510.

Who is the listed applicant for OXY-OFF(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 OXY-OFF(TM)?

The FDA product code for OXY-OFF(TM) is BXY.

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: BXY)

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.

K953506WESTMED RESPIRATORY LUER ADAPTORWestmed Intl.K902916PRECISION MEDICAL NEB BLOCKPrecision Medical, Inc.K902917PRECISION MEDICAL ELIMINATORPrecision Medical, Inc.K860516LSP MINILATORLife Support Products, Inc.K851460NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLATelectronics, Inc.K781523PFT GASESGardner Cryogenics

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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