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FDA 510(k)

NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA

K-Number: K851460 · 1985-05-10

ApplicantTelectronics, Inc.
Decision Date1985-05-10
Product CodeBXY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1985-05-10 under 510(k) number K851460. 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 NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA?

NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Telectronics, Inc.. The 510(k) number is K851460.

When did NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA receive FDA 510(k) clearance?

NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA received FDA 510(k) clearance on 1985-05-10, under 510(k) number K851460.

Who is the listed applicant for NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA?

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

What is the FDA product code for NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA?

The FDA product code for NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA is BXY.

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Other records listing Telectronics, 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.

K890895IMPLANTABLE ADAPTOR 033-380K891231OPTIMA MPT AND SPT PACEMAKERSK890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)K884411OPTIMA MPT AND SPT PACEMAKERSK884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

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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.K863510OXY-OFF(TM)B&B Medical Technologies, Inc.K860516LSP MINILATORLife Support Products, 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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