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FDA 510(k)

PEDIA PALS, INCORPORATED

K-Number: K950086 · 1995-02-07

ApplicantPedia Pals, Inc.
Decision Date1995-02-07
Product CodeEPY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PEDIA PALS, INCORPORATED 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 1995-02-07 under 510(k) number K950086. The device is classified under product code EPY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIA PALS, INCORPORATED?

PEDIA PALS, INCORPORATED is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Pedia Pals, Inc.. The 510(k) number is K950086.

When did PEDIA PALS, INCORPORATED receive FDA 510(k) clearance?

PEDIA PALS, INCORPORATED received FDA 510(k) clearance on 1995-02-07, under 510(k) number K950086.

Who is the listed applicant for PEDIA PALS, INCORPORATED?

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 PEDIA PALS, INCORPORATED?

The FDA product code for PEDIA PALS, INCORPORATED is EPY.

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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.

K951039BLOOD PRESSURE CUFF 1K951041BLOOD PRESSURE CUFF 3K951040BLOOD PRESSURE CUFF 2K951050SPECULUM, ENT (S3)K951049SPECULUM, ENT (S3)K911650PEDIA PALS

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Related Devices (Code: EPY)

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.

K925754ECONOMRudolf Riester GmbH & Co. KGK853588FIBRELIGHT NASAL SPECULADowns Surgical , Ltd.K834189JAKOBI SURG. INSTRUMENTS #7 44/47Imm Enterprises , Ltd.K822373EAR SURGERY SPECULUMTreace Medical, Inc.K822370UNIVERSAL SPECULUM HOLDERTreace Medical, Inc.K822164EAR SPECULIKelleher Corp.

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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