FDA 510(k)

6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU

K-Number: K844772 · 1986-04-17

Decision Date1986-04-17

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 1986-04-17 under 510(k) number K844772. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU?

6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU is a medical device that received FDA 510(k) clearance on 1986-04-17. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K844772.

When did 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU receive FDA 510(k) clearance?

6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU received FDA 510(k) clearance on 1986-04-17, under 510(k) number K844772.

Who is the listed applicant for 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU?

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

What is the FDA product code for 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU?

The FDA product code for 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU is ITX.

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Other records listing Philips Medical Systems, Inc. as applicant

K093355PCR ELEVA 1.2 K090808PINNACLE3 SMARTARC K071391PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 K063783PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A K041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN K040955M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN

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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.