FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHESTAC-25F SPIROMETER
K Number: K840908
·
Decision May 14, 1984
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
13
Review Days
75
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Basic Information
- Device Name
- CHESTAC-25F SPIROMETER
- K Number
- K840908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Equipment Designs, Inc.
- Date Received
- February 29, 1984
- Decision Date
- May 14, 1984
- 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 Medical Equipment Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911308 | CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE | Sep 11, 1991 | Substantially Equivalent |
| K894152 | MEDITHERM | Jun 11, 1990 | Substantially Equivalent |
| K895375 | MULTISPIRO | Nov 27, 1989 | Substantially Equivalent |
| K851277 | MICROSPIRO-SDS | Apr 19, 1985 | Substantially Equivalent |
| K840929 | FRC 85 SERIES SPIROMETER | May 14, 1984 | Substantially Equivalent |
| K821081 | CHART PROJECTOR | Jun 14, 1982 | Substantially Equivalent |
| K821084 | UNIVERSAL TRIAL FRAMEE | Jun 14, 1982 | Substantially Equivalent |
| K821107 | EXOPHTHALMOMETER | Jun 14, 1982 | Substantially Equivalent |
| K821083 | P.D. METER | Jun 14, 1982 | Substantially Equivalent |
| K821082 | TRIAL LENS SET | Jun 14, 1982 | Substantially Equivalent |