Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007

K-Number: K854654 · 1987-08-19

ApplicantPhilips Medical Systems, Inc.
Decision Date1987-08-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent for Some Indications

Device Summary

SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007 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 1987-08-19 under 510(k) number K854654. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007?

SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007 is a medical device that received FDA 510(k) clearance on 1987-08-19. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K854654.

When did SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007 receive FDA 510(k) clearance?

SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007 received FDA 510(k) clearance on 1987-08-19, under 510(k) number K854654.

Who is the listed applicant for SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007?

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 SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007?

The FDA product code for SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007 is IYO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Philips Medical Systems, 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.

K093355PCR ELEVA 1.2K090808PINNACLE3 SMARTARCK071391PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521K063783PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132AK041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIENK040955M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN

View all 111 devices →

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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.

↑