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FDA 510(k)

VITALMAX 2100/2200

K-Number: K905274 · 1991-07-17

ApplicantPace Tech, Inc.
Decision Date1991-07-17
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITALMAX 2100/2200 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 1991-07-17 under 510(k) number K905274. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALMAX 2100/2200?

VITALMAX 2100/2200 is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Pace Tech, Inc.. The 510(k) number is K905274.

When did VITALMAX 2100/2200 receive FDA 510(k) clearance?

VITALMAX 2100/2200 received FDA 510(k) clearance on 1991-07-17, under 510(k) number K905274.

Who is the listed applicant for VITALMAX 2100/2200?

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 2100/2200?

The FDA product code for VITALMAX 2100/2200 is DRT.

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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: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, 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.

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