FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
K Number: K904625
·
Decision Aug 20, 1991
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
19
Review Days
314
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Basic Information
- Device Name
- SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
- K Number
- K904625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Synectics-Dantec
- Date Received
- October 10, 1990
- Decision Date
- August 20, 1991
- Product Code
- BZG
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K924875 | MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS | Jun 30, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K914793 | MONOCRYSTANT PH/LES CATHETER, MODIFICATION | Dec 13, 1993 | Substantially Equivalent |
| K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | Jun 18, 1993 | Substantially Equivalent |
| K913817 | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | Jun 11, 1992 | Substantially Equivalent |
| K914624 | PH METER, MODIFICATION | Apr 28, 1992 | Substantially Equivalent |
| K914219 | AIRWAY THERMISTOR | Feb 26, 1992 | Substantially Equivalent |
| K913387 | DIGITRAPPER MARK III | Dec 27, 1991 | Substantially Equivalent |
| K905520 | MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION | Apr 26, 1991 | Substantially Equivalent |