FDA 510(k)

SILICONE RUBBER ISOLATION SLEEVE 351-01

K-Number: K833198 · 1983-10-27

Decision Date1983-10-27

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SILICONE RUBBER ISOLATION SLEEVE 351-01 is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1983-10-27 under 510(k) number K833198. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE RUBBER ISOLATION SLEEVE 351-01?

SILICONE RUBBER ISOLATION SLEEVE 351-01 is a medical device that received FDA 510(k) clearance on 1983-10-27. The listed applicant is Intermedics, Inc.. The 510(k) number is K833198.

When did SILICONE RUBBER ISOLATION SLEEVE 351-01 receive FDA 510(k) clearance?

SILICONE RUBBER ISOLATION SLEEVE 351-01 received FDA 510(k) clearance on 1983-10-27, under 510(k) number K833198.

Who is the listed applicant for SILICONE RUBBER ISOLATION SLEEVE 351-01?

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

What is the FDA product code for SILICONE RUBBER ISOLATION SLEEVE 351-01?

The FDA product code for SILICONE RUBBER ISOLATION SLEEVE 351-01 is DXY. This falls under the Clinical Chemistry category.

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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.