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)

NAVIGATOR APPLICATIONS SUITE

K-Number: K071097 · 2007-10-10

ApplicantGE Healthcare Finland Oy
Decision Date2007-10-10
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NAVIGATOR APPLICATIONS SUITE is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2007-10-10 under 510(k) number K071097. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGATOR APPLICATIONS SUITE?

NAVIGATOR APPLICATIONS SUITE is a medical device that received FDA 510(k) clearance on 2007-10-10. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K071097.

When did NAVIGATOR APPLICATIONS SUITE receive FDA 510(k) clearance?

NAVIGATOR APPLICATIONS SUITE received FDA 510(k) clearance on 2007-10-10, under 510(k) number K071097.

Who is the listed applicant for NAVIGATOR APPLICATIONS SUITE?

The FDA 510(k) record lists GE Healthcare Finland Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIGATOR APPLICATIONS SUITE?

The FDA product code for NAVIGATOR APPLICATIONS SUITE is BSZ.

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 GE Healthcare Finland Oy 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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayK223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)K213363CARESCAPE B450, E-musbK213336Carescape B850, E-musbK213181CARESCAPE B650, E-musb

View all 29 devices →

Related Devices (Code: BSZ)

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.

K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. KgaaK251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)Codonics.IncorporatedK230931AtlanDrägerwerk AG Co. KgaaK213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics 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.

↑