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FDA 510(k)

Boppli Infant Blood Pressure Monitor

K-Number: K223873 · 2023-09-29

ApplicantPyrames, Inc.
Decision Date2023-09-29
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Boppli Infant Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Pyrames, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K223873. 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 Boppli Infant Blood Pressure Monitor?

Boppli Infant Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Pyrames, Inc.. The 510(k) number is K223873.

When did Boppli Infant Blood Pressure Monitor receive FDA 510(k) clearance?

Boppli Infant Blood Pressure Monitor received FDA 510(k) clearance on 2023-09-29, under 510(k) number K223873.

Who is the listed applicant for Boppli Infant Blood Pressure Monitor?

The FDA 510(k) record lists Pyrames, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boppli Infant Blood Pressure Monitor?

The FDA product code for Boppli Infant Blood Pressure Monitor is DXN.

Related PubMed Literature

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.

PMID: 40388896Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates.Neonatology (2025)

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.

K261061BP Go (BPP-855)Wellvii, Inc.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.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

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