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)

HANDYPACK 911SC

K-Number: K944541 · 1995-02-22

ApplicantPace Tech, Inc.
Decision Date1995-02-22
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HANDYPACK 911SC is the device name listed in this FDA 510(k) record. The listed applicant is Pace Tech, Inc.. It received FDA 510(k) clearance on 1995-02-22 under 510(k) number K944541. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDYPACK 911SC?

HANDYPACK 911SC is a medical device that received FDA 510(k) clearance on 1995-02-22. The listed applicant is Pace Tech, Inc.. The 510(k) number is K944541.

When did HANDYPACK 911SC receive FDA 510(k) clearance?

HANDYPACK 911SC received FDA 510(k) clearance on 1995-02-22, under 510(k) number K944541.

Who is the listed applicant for HANDYPACK 911SC?

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

What is the FDA product code for HANDYPACK 911SC?

The FDA product code for HANDYPACK 911SC is CCK.

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 Pace Tech, 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.

K951226VITALMAX 4000/MINIPACK 3100/3000K953795VITALMAX 4100K945385VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300K925701MINIPACK 911-STCK934385MINIPACK 3100/3000 MODIFICATIONK933624VITALMAX 4000

View all 18 devices →

Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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.

↑