Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEBU-SOL METERED DOSE DISPENSER (TM)

K-Number: K910239 · 1991-05-22

ApplicantDey Laboratories, Inc.
Decision Date1991-05-22
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEBU-SOL METERED DOSE DISPENSER (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Dey Laboratories, Inc.. It received FDA 510(k) clearance on 1991-05-22 under 510(k) number K910239. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEBU-SOL METERED DOSE DISPENSER (TM)?

NEBU-SOL METERED DOSE DISPENSER (TM) is a medical device that received FDA 510(k) clearance on 1991-05-22. The listed applicant is Dey Laboratories, Inc.. The 510(k) number is K910239.

When did NEBU-SOL METERED DOSE DISPENSER (TM) receive FDA 510(k) clearance?

NEBU-SOL METERED DOSE DISPENSER (TM) received FDA 510(k) clearance on 1991-05-22, under 510(k) number K910239.

Who is the listed applicant for NEBU-SOL METERED DOSE DISPENSER (TM)?

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

What is the FDA product code for NEBU-SOL METERED DOSE DISPENSER (TM)?

The FDA product code for NEBU-SOL METERED DOSE DISPENSER (TM) is BSY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dey Laboratories, 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.

K972778DEY VIAL SODIUM CHLORIDE 3%K880411DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILEK875011DEY-PAK PURIFIED WATER, USP, STERILEK875024DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USPK831532OCULAR IRRIGATING CANNULA

Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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.

↑