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)

PRESSURE INFUSION PUMP

K-Number: K813105 · 1981-12-14

ApplicantCalbio, Inc.
Decision Date1981-12-14
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESSURE INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Calbio, Inc.. It received FDA 510(k) clearance on 1981-12-14 under 510(k) number K813105. The device is classified under product code KZD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE INFUSION PUMP?

PRESSURE INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1981-12-14. The listed applicant is Calbio, Inc.. The 510(k) number is K813105.

When did PRESSURE INFUSION PUMP receive FDA 510(k) clearance?

PRESSURE INFUSION PUMP received FDA 510(k) clearance on 1981-12-14, under 510(k) number K813105.

Who is the listed applicant for PRESSURE INFUSION PUMP?

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

What is the FDA product code for PRESSURE INFUSION PUMP?

The FDA product code for PRESSURE INFUSION PUMP is KZD.

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 Calbio, 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.

K832629INTUBATION KIT

Related Devices (Code: KZD)

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.

K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.K973843MSI PRESSURE INFUSORSmith Assoc.K953290OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMPOlympus America, Inc.K951988PRESSURIZERPromedic, Inc.K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories 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.

↑