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)

AMBULATORY PH DATA RECORDER SYSTEM, APH-2000

K-Number: K882551 · 1988-10-12

ApplicantIntl. Biomedics, Inc.
Decision Date1988-10-12
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Biomedics, Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K882551. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBULATORY PH DATA RECORDER SYSTEM, APH-2000?

AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Intl. Biomedics, Inc.. The 510(k) number is K882551.

When did AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 receive FDA 510(k) clearance?

AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 received FDA 510(k) clearance on 1988-10-12, under 510(k) number K882551.

Who is the listed applicant for AMBULATORY PH DATA RECORDER SYSTEM, APH-2000?

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

What is the FDA product code for AMBULATORY PH DATA RECORDER SYSTEM, APH-2000?

The FDA product code for AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 is KLA.

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 Intl. Biomedics, 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.

K854065INFANT LIFE SUPPORT MODULE-20

Related Devices (Code: KLA)

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.

K242666Fecobionics Anorectal SystemGi Bionics, LLCK242304REDNeuraxis, Inc.K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp.K180135THD Anopress with THD SensyProbeThd SpaK161785THD ANOPRESSThd SpaK120088MCOMPASS ANORECTAL MANOMETRY SYSTEMMedspira, LLC

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.

↑