FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIROMETRICS BREON 2400 & SMI 2400
K Number: K831497
·
Decision Jun 24, 1983
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
11
Review Days
45
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Basic Information
- Device Name
- SPIROMETRICS BREON 2400 & SMI 2400
- K Number
- K831497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Spirometrics, Inc.
- Date Received
- May 10, 1983
- Decision Date
- June 24, 1983
- 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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Other Clearances by Spirometrics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915059 | PEAK FLOW MONITOR | Jul 27, 1992 | Substantially Equivalent |
| K911358 | CMD/DLCO DIAGNOSTIC SPIROMETER | Jul 22, 1991 | Substantially Equivalent |
| K900322 | CO/CMD-1 | Apr 30, 1990 | Substantially Equivalent |
| K901057 | SPIROMETRICS MODEL 2600 MIRO SPIROMETER | Apr 3, 1990 | Substantially Equivalent |
| K900673 | SERIAL FLOW | Apr 3, 1990 | Substantially Equivalent |
| K884464 | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | Jan 19, 1989 | Substantially Equivalent |
| K884465 | SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM) | Nov 9, 1988 | Substantially Equivalent |
| K863953 | SPIROMETRICS MODEL 2500 FLOWMATE(TM) | Jan 15, 1987 | Substantially Equivalent |
| K850045 | SPIROMETRICS 2453 & SMI III | Feb 14, 1985 | Substantially Equivalent |
| K844333 | SPIROMETRICS 2451 & SMI I | Nov 20, 1984 | Substantially Equivalent |