FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
K Number: K924875
·
Decision Jun 30, 1994
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
19
Review Days
654
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Basic Information
- Device Name
- MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
- K Number
- K924875
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Synectics-Dantec
- Date Received
- September 14, 1992
- Decision Date
- June 30, 1994
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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Other Clearances by Synectics-Dantec
| K Number | Device Name | ||
|---|---|---|---|
| K961346 | PH ANALYSIS MODULE | Jan 29, 1997 | Substantially Equivalent |
| K925405 | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. | Sep 30, 1994 | Substantially Equivalent |
| 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 |
| K904625 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM | Aug 20, 1991 | Substantially Equivalent |
| K905520 | MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION | Apr 26, 1991 | Substantially Equivalent |