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FDA 510(k)

E-READER

K-Number: K970436 · 1997-08-15

ApplicantNatural Herbal Products, Inc.
Decision Date1997-08-15
Product CodeGZO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

E-READER is the device name listed in this FDA 510(k) record. The listed applicant is Natural Herbal Products, Inc.. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K970436. The device is classified under product code GZO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-READER?

E-READER is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Natural Herbal Products, Inc.. The 510(k) number is K970436.

When did E-READER receive FDA 510(k) clearance?

E-READER received FDA 510(k) clearance on 1997-08-15, under 510(k) number K970436.

Who is the listed applicant for E-READER?

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

What is the FDA product code for E-READER?

The FDA product code for E-READER is GZO.

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Related Devices (Code: GZO)

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.

K131568SUDO PATHLd Technology, LLCK111308ZYTO HAND CRADLEZyto Technologies, Inc.K102166ELECTRO INTERSTITIAL SCANLd Technology, LLCK100233SUDOSCANImpeto MedicalK053004MSAS-VANTAGEBiomeridian, Int.K032935EPI-SCAN, MODEL P 100Edx Epi-Scan, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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