FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIROLITE MODEL MSC-201 SPIROMETER
K Number: K921513
·
Decision Jan 27, 1993
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
8
Review Days
302
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Basic Information
- Device Name
- SPIROLITE MODEL MSC-201 SPIROMETER
- K Number
- K921513
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Systems Corp.
- Date Received
- March 31, 1992
- Decision Date
- January 27, 1993
- 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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|---|---|---|---|
| K931736 | M-FLEX 5000 C3PMD | Jan 27, 1994 | Substantially Equivalent |
| K921485 | LA MONT VIDEO PATIENT MONITORING SYSTEM | Oct 22, 1992 | Substantially Equivalent |
| K904353 | CARDIOMATIC MODEL MSC-2001 | Dec 20, 1990 | Substantially Equivalent |
| K903501 | RADIANT TEMPERATUR INDICATOR MODEL 25E | Sep 12, 1990 | Substantially Equivalent |
| K902192 | MODEL MSC SA02-5000 PULSE OXIMETER | Aug 23, 1990 | Substantially Equivalent |
| K902608 | CARDIOMATIC MODEL MSC-1001 | Jul 13, 1990 | Substantially Equivalent |
| K770878 | SIGNAL PROCESSOR/AVERAGER MODEL 7S11 | Jun 1, 1977 | Substantially Equivalent |