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FDA 510(k)

AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR

K-Number: K971492 · 1997-09-05

ApplicantBei Medical Systems Co., Inc.
Decision Date1997-09-05
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bei Medical Systems Co., Inc.. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K971492. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR?

AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Bei Medical Systems Co., Inc.. The 510(k) number is K971492.

When did AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR receive FDA 510(k) clearance?

AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR received FDA 510(k) clearance on 1997-09-05, under 510(k) number K971492.

Who is the listed applicant for AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR?

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

What is the FDA product code for AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR?

The FDA product code for AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR is HIG.

Related Clinical Trials

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.

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Other records listing Bei Medical Systems Co., 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.

K950663BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATORK934286HYSTEROSCOPEK940266BEI MEDICAL SYSTEMS' SMOKE EVACUATOR

Related Devices (Code: HIG)

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.

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys Fluid Management SystemBoston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KG

Official Source

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