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)

CAVI-MED

K-Number: K842581 · 1984-08-03

ApplicantCooper Lasersonics, Inc.
Decision Date1984-08-03
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAVI-MED is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1984-08-03 under 510(k) number K842581. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAVI-MED?

CAVI-MED is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K842581.

When did CAVI-MED receive FDA 510(k) clearance?

CAVI-MED received FDA 510(k) clearance on 1984-08-03, under 510(k) number K842581.

Who is the listed applicant for CAVI-MED?

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

What is the FDA product code for CAVI-MED?

The FDA product code for CAVI-MED is ELC.

Other records listing Cooper Lasersonics, 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.

K880808ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SUK880807ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SUK880427ILLUMINA 40 CO2 LASER SYSTEMK880428ILLUMINA 25 CO2 LASER SYSTEMK880429ILLUMINA 55 CO2 LASER SYSTEMK880809ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU

View all 54 devices →

Related Devices (Code: ELC)

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.

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AK251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)Nakanishi, Inc.K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)Shenzhen Micro Electric Intelligence Co., Ltd.

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.

↑