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)

LKB-BROMMA 2188 ULTROTOME NOVA

K-Number: K812158 · 1981-09-16

ApplicantLkb Instruments, Inc.
Decision Date1981-09-16
Product CodeIDM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

LKB-BROMMA 2188 ULTROTOME NOVA is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1981-09-16 under 510(k) number K812158. The device is classified under product code IDM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LKB-BROMMA 2188 ULTROTOME NOVA?

LKB-BROMMA 2188 ULTROTOME NOVA is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K812158.

When did LKB-BROMMA 2188 ULTROTOME NOVA receive FDA 510(k) clearance?

LKB-BROMMA 2188 ULTROTOME NOVA received FDA 510(k) clearance on 1981-09-16, under 510(k) number K812158.

Who is the listed applicant for LKB-BROMMA 2188 ULTROTOME NOVA?

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

What is the FDA product code for LKB-BROMMA 2188 ULTROTOME NOVA?

The FDA product code for LKB-BROMMA 2188 ULTROTOME NOVA is IDM.

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 Lkb Instruments, 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.

K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTERK872955DELFIA(TM) FERRITIN KITK871303DELFIA(TM) THYROXINE (T4) KITK871599DELFIA(TM) HIGE KITK871644DELFIA (TM) HTSH KITK864452DELFIA(TM) TRIIODOTHYRONINE (T3) KIT

View all 52 devices →

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.

↑