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FDA 510(k)

MINIPACK 3100/3000 MODIFICATION

K-Number: K934385 · 1994-08-10

ApplicantPace Tech, Inc.
Decision Date1994-08-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINIPACK 3100/3000 MODIFICATION 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 1994-08-10 under 510(k) number K934385. 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 MINIPACK 3100/3000 MODIFICATION?

MINIPACK 3100/3000 MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-08-10. The listed applicant is Pace Tech, Inc.. The 510(k) number is K934385.

When did MINIPACK 3100/3000 MODIFICATION receive FDA 510(k) clearance?

MINIPACK 3100/3000 MODIFICATION received FDA 510(k) clearance on 1994-08-10, under 510(k) number K934385.

Who is the listed applicant for MINIPACK 3100/3000 MODIFICATION?

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 MINIPACK 3100/3000 MODIFICATION?

The FDA product code for MINIPACK 3100/3000 MODIFICATION 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-STCK933624VITALMAX 4000

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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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