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FDA 510(k)

IRRIGATOR, BODY CAVITY

K-Number: K781918 · 1979-02-15

ApplicantBci, Inc.
Decision Date1979-02-15
Product CodeEYN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IRRIGATOR, BODY CAVITY is the device name listed in this FDA 510(k) record. The listed applicant is Bci, Inc.. It received FDA 510(k) clearance on 1979-02-15 under 510(k) number K781918. The device is classified under product code EYN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATOR, BODY CAVITY?

IRRIGATOR, BODY CAVITY is a medical device that received FDA 510(k) clearance on 1979-02-15. The listed applicant is Bci, Inc.. The 510(k) number is K781918.

When did IRRIGATOR, BODY CAVITY receive FDA 510(k) clearance?

IRRIGATOR, BODY CAVITY received FDA 510(k) clearance on 1979-02-15, under 510(k) number K781918.

Who is the listed applicant for IRRIGATOR, BODY CAVITY?

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

What is the FDA product code for IRRIGATOR, BODY CAVITY?

The FDA product code for IRRIGATOR, BODY CAVITY is EYN.

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Other records listing Bci, 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.

K030407ADVISOR, MODEL 9200K031742BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETERK020739BCI 3178 PEDIATRIC PULSE OXIMETRY SENSORK020350BCI 3180 PULSE OXIMETERK013862BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAMK0131713420 DIGIT PULSE OXIMETER, MODEL 3420

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Related Devices (Code: EYN)

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.

K944882IRRIGATION TRAYClinical Resources, Inc.K923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEAmerican Healthcare Corp.K923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEAmerican Healthcare Corp.K923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERAmerican Healthcare Corp.K923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERAmerican Healthcare Corp.K900148KIT PAK IRRIGATION TRAYKit Pak, 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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