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)

6004 NIBP MONITOR WITH TEMPERATURE

K-Number: K983796 · 1999-01-22

ApplicantBci Intl., Inc.
Decision Date1999-01-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

6004 NIBP MONITOR WITH TEMPERATURE is the device name listed in this FDA 510(k) record. The listed applicant is Bci Intl., Inc.. It received FDA 510(k) clearance on 1999-01-22 under 510(k) number K983796. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6004 NIBP MONITOR WITH TEMPERATURE?

6004 NIBP MONITOR WITH TEMPERATURE is a medical device that received FDA 510(k) clearance on 1999-01-22. The listed applicant is Bci Intl., Inc.. The 510(k) number is K983796.

When did 6004 NIBP MONITOR WITH TEMPERATURE receive FDA 510(k) clearance?

6004 NIBP MONITOR WITH TEMPERATURE received FDA 510(k) clearance on 1999-01-22, under 510(k) number K983796.

Who is the listed applicant for 6004 NIBP MONITOR WITH TEMPERATURE?

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

What is the FDA product code for 6004 NIBP MONITOR WITH TEMPERATURE?

The FDA product code for 6004 NIBP MONITOR WITH TEMPERATURE is DXN.

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 Bci Intl., 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.

K9914103402 HANDHELD PULSE OXIMETERK991086CAPNOCHECK II, MODEL 8400K984618BCI MINI-TORR PLUS, MODEL 6004K982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200K981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITORK980714BCI 3401 HANDHELD PULSE OXIMETER

View all 20 devices →

Related Devices (Code: DXN)

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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, 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.

↑