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FDA 510(k)

NERVE STIMULATOR, MOLEL NO. FB-800

K-Number: K770987 · 1977-06-14

ApplicantOutput, Inc.
Decision Date1977-06-14
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NERVE STIMULATOR, MOLEL NO. FB-800 is the device name listed in this FDA 510(k) record. The listed applicant is Output, Inc.. It received FDA 510(k) clearance on 1977-06-14 under 510(k) number K770987. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NERVE STIMULATOR, MOLEL NO. FB-800?

NERVE STIMULATOR, MOLEL NO. FB-800 is a medical device that received FDA 510(k) clearance on 1977-06-14. The listed applicant is Output, Inc.. The 510(k) number is K770987.

When did NERVE STIMULATOR, MOLEL NO. FB-800 receive FDA 510(k) clearance?

NERVE STIMULATOR, MOLEL NO. FB-800 received FDA 510(k) clearance on 1977-06-14, under 510(k) number K770987.

Who is the listed applicant for NERVE STIMULATOR, MOLEL NO. FB-800?

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

What is the FDA product code for NERVE STIMULATOR, MOLEL NO. FB-800?

The FDA product code for NERVE STIMULATOR, MOLEL NO. FB-800 is GZI.

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 Output, 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.

K800360OUTPUT DIGITAL DISPLAY MODULE, MOD. 611K781115PRINTER, DIGITALK780356OUTPUT DIGITAL DISPLAY MODULE, MODEL 401K760614PERIPHERAL NERVE STIMULATOR

Related Devices (Code: GZI)

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.

K242704Synchrony (20-3000)Synapse Biomedical, Inc.K243828CIONIC NEURAL SLEEVE (NS-200)Cionic, Inc.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 SystemEvolution Devices, Inc.K221823Cionic Neural Sleeve NS-100Cionic

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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