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FDA 510(k)

SPRIO-LOOP

K-Number: K811419 · 1981-06-12

ApplicantDatamed, Inc.
Decision Date1981-06-12
Product CodeBTX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPRIO-LOOP is the device name listed in this FDA 510(k) record. The listed applicant is Datamed, Inc.. It received FDA 510(k) clearance on 1981-06-12 under 510(k) number K811419. The device is classified under product code BTX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPRIO-LOOP?

SPRIO-LOOP is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is Datamed, Inc.. The 510(k) number is K811419.

When did SPRIO-LOOP receive FDA 510(k) clearance?

SPRIO-LOOP received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811419.

Who is the listed applicant for SPRIO-LOOP?

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

What is the FDA product code for SPRIO-LOOP?

The FDA product code for SPRIO-LOOP is BTX.

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 Datamed, 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.

K904966DATAMED MODEL 401A TRANSRECIEVERK841858SPIROLOOP

Related Devices (Code: BTX)

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.

K935098BABY BOARDSentry Medical Products, Inc.K9001754/1 ARMBOARDInfection Control Products, Inc.K884838ALLEN PRONE ARMBOARDEdgewater Medical Systems, Inc.K882524UNIVERSALLY ADJUSTABLE ARMBOARDKarlin Technology, Inc.K881292ALLEN LATERAL ARMBOARDEdgewater Medical Systems, Inc.K864670BOARD, ARM (WITH COVER)Anago, 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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