SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007— 510(k) K854654
Substantially Equivalent for Some IndicationsPhilips Medical Systems, Inc.
FDA 510(k) clearance K854654 for SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007, Substantially Equivalent for Some Indications on 1987-08-19. Applicant: Philips Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Recent devices under product code IYO
view allMore clearances from Philips Medical Systems, Inc.
view all- K093355 — PCR ELEVA 1.2
- K090808 — PINNACLE3 SMARTARC
- K071391 — PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
- K063783 — PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
- K041741 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.