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FDA 510(k)

LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM

K-Number: K913472 · 1992-03-13

ApplicantBaxter Healthcare Corp
Decision Date1992-03-13
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1992-03-13 under 510(k) number K913472. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM?

LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1992-03-13. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K913472.

When did LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM receive FDA 510(k) clearance?

LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM received FDA 510(k) clearance on 1992-03-13, under 510(k) number K913472.

Who is the listed applicant for LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM?

The FDA product code for LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM is ITX.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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