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FDA 510(k)

VITALMAX 4100

K-Number: K953795 · 1996-07-01

ApplicantPace Tech, Inc.
Decision Date1996-07-01
Product CodeCBS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VITALMAX 4100 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 1996-07-01 under 510(k) number K953795. The device is classified under product code CBS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALMAX 4100?

VITALMAX 4100 is a medical device that received FDA 510(k) clearance on 1996-07-01. The listed applicant is Pace Tech, Inc.. The 510(k) number is K953795.

When did VITALMAX 4100 receive FDA 510(k) clearance?

VITALMAX 4100 received FDA 510(k) clearance on 1996-07-01, under 510(k) number K953795.

Who is the listed applicant for VITALMAX 4100?

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 4100?

The FDA product code for VITALMAX 4100 is CBS.

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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.

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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 3100/3000K944541HANDYPACK 911SCK945385VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300K925701MINIPACK 911-STCK934385MINIPACK 3100/3000 MODIFICATIONK933624VITALMAX 4000

View all 18 devices →

Related Devices (Code: CBS)

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.

K974903GAS MODULE II, MODEL 0998-00-0143Datascope Corp.K960490AS/3 COMPACT AIRWAY MODULE M-CAIOVDatex Medical Instrumentation, Inc.K951366RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)Riken Keiki Co., Ltd.K950101RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITORMarquette Electronics, Inc.K943458AS/3 AIRWAY MODULEDatex Division Instrumentarium Corp.K942737POET IQ WITH FIVE AGENT CAPABILITYCriticare Systems, 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.

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