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FDA 510(k)

PG-800A SERIES

K-Number: K131569 · 2013-06-14

ApplicantShenzhen Pango Electronic Co., Ltd.
Decision Date2013-06-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PG-800A SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Pango Electronic Co., Ltd.. It received FDA 510(k) clearance on 2013-06-14 under 510(k) number K131569. 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 PG-800A SERIES?

PG-800A SERIES is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Shenzhen Pango Electronic Co., Ltd.. The 510(k) number is K131569.

When did PG-800A SERIES receive FDA 510(k) clearance?

PG-800A SERIES received FDA 510(k) clearance on 2013-06-14, under 510(k) number K131569.

Who is the listed applicant for PG-800A SERIES?

The FDA 510(k) record lists Shenzhen Pango Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PG-800A SERIES?

The FDA product code for PG-800A SERIES is DXN.

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Other records listing Shenzhen Pango Electronic Co., Ltd. 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.

K203746Venen-trainer (Model: FM150, SFM90)K200716Electronic Blood Pressure MonitorK182597Infrared thermometerK170151Electronic Blood Pressure MonitorK161845Electronic Blood Pressure MonitorK131558PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6

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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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