FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIROSCOPE
K Number: K905480
·
Decision May 6, 1991
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
8
Review Days
151
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Basic Information
- Device Name
- SPIROSCOPE
- K Number
- K905480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Grandcor Medical Systems
- Date Received
- December 6, 1990
- Decision Date
- May 6, 1991
- Product Code
- BZC
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
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Other Clearances by Grandcor Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K895547 | GRANDCOR/CARDIOLINE ECT STRESS TESTING | Mar 13, 1990 | Substantially Equivalent |
| K883410 | CARDIOMEGA-T | Oct 17, 1988 | Substantially Equivalent |
| K871890 | CARDIO-MEGA SYSTEM | Jun 12, 1987 | Substantially Equivalent |
| K864260 | APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) | May 11, 1987 | Substantially Equivalent |
| K864978 | APPLISCOPE | Feb 19, 1987 | Substantially Equivalent |
| K864581 | APPLIDYN | Jan 21, 1987 | Substantially Equivalent |
| K862375 | CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM | Jul 1, 1986 | Substantially Equivalent |