FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITALOGRAPH DATA STORAGE SPIROMETER
K Number: K930085
·
Decision Jul 26, 1993
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
17
Review Days
200
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Basic Information
- Device Name
- VITALOGRAPH DATA STORAGE SPIROMETER
- K Number
- K930085
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vitalograph , Ltd.
- Date Received
- January 7, 1993
- Decision Date
- July 26, 1993
- Product Code
- BTY
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
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Other Clearances by Vitalograph , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253293 | VitaloJAK Clinic (Model 7100) | Dec 3, 2025 | Substantially Equivalent |
| K950854 | VITALOGRAPH 2110 SOFTWARE INTERFACE | Oct 12, 1995 | Substantially Equivalent |
| K925085 | ESCORT SPIROMETER | Aug 12, 1993 | Substantially Equivalent |
| K912412 | VITALOGRAPH SPIROTRAC III | Oct 15, 1991 | Substantially Equivalent |
| K893665 | AEROSOL INHALATION MONITOR | Aug 21, 1989 | Substantially Equivalent |
| K892524 | VITALOGRAPH-BREATHCO MONITOR | May 5, 1989 | Substantially Equivalent |
| K873562 | VITALOGRAPH-ALPHA | Aug 29, 1988 | Substantially Equivalent |
| K874892 | VITALOGRAPH-EC60 HYDROGEN MONITOR | Jun 2, 1988 | Substantially Equivalent |
| K863420 | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR | Jan 15, 1987 | Substantially Equivalent |
| K860949 | DUAL-AID | May 6, 1986 | Substantially Equivalent |