FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEAK FLOW METER
K Number: K970507
·
Decision Jun 13, 1997
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
17
Review Days
123
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Basic Information
- Device Name
- PEAK FLOW METER
- K Number
- K970507
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intl. Medical, Inc.
- Date Received
- February 10, 1997
- Decision Date
- June 13, 1997
- Product Code
- BZH
- 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 |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | FDA class 2 | Anesthesiology |
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|---|---|---|---|
| K943078 | HOT BIOPSY FORCEPS | Nov 14, 1994 | Substantially Equivalent |
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| K940335 | AMERICAN CATHETER POLY-SNARE | Jul 21, 1994 | Substantially Equivalent |
| K942068 | AMERICAN CATHETER SPHINCTEROTOME | Jun 24, 1994 | Substantially Equivalent |
| K930406 | DURHAM; MIN BORE LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K930410 | DURHAM; LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K923200 | AMCATH DISPOSABLE CYTOLOGY BRUSH | Dec 7, 1992 | Substantially Equivalent |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | Jan 10, 1992 | Substantially Equivalent |
| K912927 | AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE | Sep 19, 1991 | Substantially Equivalent |
| K912605 | AMCATH DISPOSABLE MICRO SCISSORS | Jul 11, 1991 | Substantially Equivalent |