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FDA 510(k)

PEDIA PALS

K-Number: K911650 · 1991-10-17

ApplicantPedia Pals, Inc.
Decision Date1991-10-17
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PEDIA PALS 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 1991-10-17 under 510(k) number K911650. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIA PALS?

PEDIA PALS is a medical device that received FDA 510(k) clearance on 1991-10-17. The listed applicant is Pedia Pals, Inc.. The 510(k) number is K911650.

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

PEDIA PALS received FDA 510(k) clearance on 1991-10-17, under 510(k) number K911650.

Who is the listed applicant for PEDIA PALS?

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?

The FDA product code for PEDIA PALS is ERA.

Related Clinical Trials

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 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)K950086PEDIA PALS, INCORPORATED

View all 7 devices →

Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, 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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