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FDA 510(k)

MODEL DT-BAL, BALANCE SAVER

K-Number: K895323 · 1989-10-24

ApplicantSpectramed, Inc.
Decision Date1989-10-24
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL DT-BAL, BALANCE SAVER is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K895323. The device is classified under product code KXO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL DT-BAL, BALANCE SAVER?

MODEL DT-BAL, BALANCE SAVER is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Spectramed, Inc.. The 510(k) number is K895323.

When did MODEL DT-BAL, BALANCE SAVER receive FDA 510(k) clearance?

MODEL DT-BAL, BALANCE SAVER received FDA 510(k) clearance on 1989-10-24, under 510(k) number K895323.

Who is the listed applicant for MODEL DT-BAL, BALANCE SAVER?

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

What is the FDA product code for MODEL DT-BAL, BALANCE SAVER?

The FDA product code for MODEL DT-BAL, BALANCE SAVER is KXO.

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Other records listing Spectramed, 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.

K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPEDK892941CCO SYSTEM MODEL SP1467,SP5567,SP6267K894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUPK881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.K881825MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH

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Related Devices (Code: KXO)

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.

K991235SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)Ludlow Technical ProductsK982565EASY TRANS TIPCarl SchuhK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)Graphic Controls Corp.K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)Graphic Controls Corp.K961290IUP - TIP TRANS, IUP - PROXI TRANSScientific Device Manufacturer, LLCK950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERGraphic Controls Corp.

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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