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FDA 510(k)

SN-100 DOCTOR'S ROUND

K-Number: K823226 · 1982-11-22

ApplicantKells Medical, Inc.
Decision Date1982-11-22
Product CodeETF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SN-100 DOCTOR'S ROUND is the device name listed in this FDA 510(k) record. The listed applicant is Kells Medical, Inc.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823226. The device is classified under product code ETF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SN-100 DOCTOR'S ROUND?

SN-100 DOCTOR'S ROUND is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Kells Medical, Inc.. The 510(k) number is K823226.

When did SN-100 DOCTOR'S ROUND receive FDA 510(k) clearance?

SN-100 DOCTOR'S ROUND received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823226.

Who is the listed applicant for SN-100 DOCTOR'S ROUND?

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

What is the FDA product code for SN-100 DOCTOR'S ROUND?

The FDA product code for SN-100 DOCTOR'S ROUND is ETF.

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Other records listing Kells Medical, 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.

K926333CPR PLUSK890093PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SETK890094EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK890095PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK861972DERMISTRIPK844463DERMIDRESS

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Related Devices (Code: ETF)

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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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