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)

VITALMAX 510/520

K-Number: K912880 · 1991-11-14

ApplicantPace Tech, Inc.
Decision Date1991-11-14
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITALMAX 510/520 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 1991-11-14 under 510(k) number K912880. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALMAX 510/520?

VITALMAX 510/520 is a medical device that received FDA 510(k) clearance on 1991-11-14. The listed applicant is Pace Tech, Inc.. The 510(k) number is K912880.

When did VITALMAX 510/520 receive FDA 510(k) clearance?

VITALMAX 510/520 received FDA 510(k) clearance on 1991-11-14, under 510(k) number K912880.

Who is the listed applicant for VITALMAX 510/520?

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 VITALMAX 510/520?

The FDA product code for VITALMAX 510/520 is DQA.

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 4100K944541HANDYPACK 911SCK945385VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300K925701MINIPACK 911-STCK934385MINIPACK 3100/3000 MODIFICATION

View all 18 devices →

Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply 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.

↑