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FDA 510(k)

VITAL SYSTEM

K-Number: K880351 · 1988-03-22

ApplicantPace Tech, Inc.
Decision Date1988-03-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAL SYSTEM 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 1988-03-22 under 510(k) number K880351. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SYSTEM?

VITAL SYSTEM is a medical device that received FDA 510(k) clearance on 1988-03-22. The listed applicant is Pace Tech, Inc.. The 510(k) number is K880351.

When did VITAL SYSTEM receive FDA 510(k) clearance?

VITAL SYSTEM received FDA 510(k) clearance on 1988-03-22, under 510(k) number K880351.

Who is the listed applicant for VITAL SYSTEM?

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 VITAL SYSTEM?

The FDA product code for VITAL SYSTEM is DXN.

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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 3100/3000K953795VITALMAX 4100K944541HANDYPACK 911SCK945385VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300K925701MINIPACK 911-STCK934385MINIPACK 3100/3000 MODIFICATION

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Related Devices (Code: DXN)

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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, 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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