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FDA 510(k)

BLOOD PRESSURE CUFF 1

K-Number: K951039 · 1995-10-31

ApplicantPedia Pals, Inc.
Decision Date1995-10-31
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD PRESSURE CUFF 1 is the device name listed in this FDA 510(k) record. The listed applicant is Pedia Pals, Inc.. It received FDA 510(k) clearance on 1995-10-31 under 510(k) number K951039. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD PRESSURE CUFF 1?

BLOOD PRESSURE CUFF 1 is a medical device that received FDA 510(k) clearance on 1995-10-31. The listed applicant is Pedia Pals, Inc.. The 510(k) number is K951039.

When did BLOOD PRESSURE CUFF 1 receive FDA 510(k) clearance?

BLOOD PRESSURE CUFF 1 received FDA 510(k) clearance on 1995-10-31, under 510(k) number K951039.

Who is the listed applicant for BLOOD PRESSURE CUFF 1?

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

What is the FDA product code for BLOOD PRESSURE CUFF 1?

The FDA product code for BLOOD PRESSURE CUFF 1 is DXQ.

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Other records listing Pedia Pals, 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.

K951041BLOOD PRESSURE CUFF 3K951040BLOOD PRESSURE CUFF 2K951050SPECULUM, ENT (S3)K951049SPECULUM, ENT (S3)K950086PEDIA PALS, INCORPORATEDK911650PEDIA PALS

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Related Devices (Code: DXQ)

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.

K254287Medline Reusable Blood Pressure CuffMedline Industries, LPK260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden CorporationK253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)Shenzhen Best Electronics Co., Ltd.K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc.K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare CorporationK250765AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation

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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