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FDA 510(k)

VITALMAX 830 SERIES

K-Number: K913263 · 1991-10-10

ApplicantPace Tech, Inc.
Decision Date1991-10-10
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITALMAX 830 SERIES 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 1991-10-10 under 510(k) number K913263. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALMAX 830 SERIES?

VITALMAX 830 SERIES is a medical device that received FDA 510(k) clearance on 1991-10-10. The listed applicant is Pace Tech, Inc.. The 510(k) number is K913263.

When did VITALMAX 830 SERIES receive FDA 510(k) clearance?

VITALMAX 830 SERIES received FDA 510(k) clearance on 1991-10-10, under 510(k) number K913263.

Who is the listed applicant for VITALMAX 830 SERIES?

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 830 SERIES?

The FDA product code for VITALMAX 830 SERIES is MHX.

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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

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Related Devices (Code: MHX)

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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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.

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