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FDA 510(k)

MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE

K-Number: K964779 · 1997-08-27

ApplicantQuantum Loop, Inc.
Decision Date1997-08-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Loop, Inc.. It received FDA 510(k) clearance on 1997-08-27 under 510(k) number K964779. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE?

MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-08-27. The listed applicant is Quantum Loop, Inc.. The 510(k) number is K964779.

When did MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE receive FDA 510(k) clearance?

MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE received FDA 510(k) clearance on 1997-08-27, under 510(k) number K964779.

Who is the listed applicant for MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE?

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

What is the FDA product code for MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE?

The FDA product code for MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE is GEI.

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Official Source

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