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FDA 510(k)

IBC CARDIAC SUCTION WARD

K-Number: K963756 · 1997-11-14

ApplicantInternational Biophysics Corp.
Decision Date1997-11-14
Product CodeDTS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IBC CARDIAC SUCTION WARD is the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corp.. It received FDA 510(k) clearance on 1997-11-14 under 510(k) number K963756. The device is classified under product code DTS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBC CARDIAC SUCTION WARD?

IBC CARDIAC SUCTION WARD is a medical device that received FDA 510(k) clearance on 1997-11-14. The listed applicant is International Biophysics Corp.. The 510(k) number is K963756.

When did IBC CARDIAC SUCTION WARD receive FDA 510(k) clearance?

IBC CARDIAC SUCTION WARD received FDA 510(k) clearance on 1997-11-14, under 510(k) number K963756.

Who is the listed applicant for IBC CARDIAC SUCTION WARD?

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

What is the FDA product code for IBC CARDIAC SUCTION WARD?

The FDA product code for IBC CARDIAC SUCTION WARD is DTS.

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Other records listing International Biophysics Corp. 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.

K072688LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000K030181INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEMK992657IBC VRV, MODEL 1350K992785IBC FLOGUARD, MODEL 6050K992964IBC VENT VALVE, MODEL 1400K983272IBC FLOPUMP, MODEL 6000

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Related Devices (Code: DTS)

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.

K053021ESTECH CLEARVIEW MV ATRIAL DEPRESSOREstech, Inc.K982891CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSCalifornia Medical Laboratories, Inc.K905008FLEXIBLE INTRACARDIAC SUCTION DEVICEGish Biomedical, Inc.K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESShiley, Inc.K891906ROBICSEK INTRACARDIAC SUCTION WANDGish Biomedical, Inc.K801641OHIO DISPOSABLE CLEAR SUCTION INSTRUMENTOhio Medical Products

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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