FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
GYROSCAN S15/ACS
K Number: K902799
·
Decision Oct 23, 1990
Classifications
1
FEI Numbers
152
Registration Numbers
152
Same Product Code
1071
Applicant Total
111
Review Days
118
Basic Information
- Device Name
- GYROSCAN S15/ACS
- K Number
- K902799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- PHILIPS MEDICAL SYSTEMS, INC.
- Date Received
- June 27, 1990
- Decision Date
- October 23, 1990
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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|---|---|---|---|
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| K041741 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN | Jul 21, 2004 | Substantially Equivalent |
| K040955 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN | May 12, 2004 | Substantially Equivalent |
| K040404 | HEARTSTART MRX, MODEL M3535A | May 4, 2004 | Substantially Equivalent |
| K040357 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II | Mar 3, 2004 | Substantially Equivalent |
| K032979 | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T | Feb 20, 2004 | Substantially Equivalent |
| K033715 | PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER | Feb 13, 2004 | Substantially Equivalent |