FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED ASSESS(R) PEAK FLOW METER
K Number: K896953
·
Decision Jan 30, 1990
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
13
Review Days
56
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Basic Information
- Device Name
- MODIFIED ASSESS(R) PEAK FLOW METER
- K Number
- K896953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Health Products, Inc.
- Date Received
- December 5, 1989
- Decision Date
- January 30, 1990
- 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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Other Clearances by Health Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912866 | PEAK EXPIRATORY FLOW METER | Aug 13, 1992 | Substantially Equivalent |
| K912943 | THRESHOLD 2X INSPIRATORY MUSCLE TRAINER | Jan 30, 1992 | Substantially Equivalent |
| K911807 | METERED DOSE INHALER (MDI) SPACER | Oct 23, 1991 | Substantially Equivalent |
| K902292 | MODIFIED ASSESS(R) PEAK FLOW METER | Aug 10, 1990 | Substantially Equivalent |
| K894353 | ORTHODERM CONVERTIBLE | Aug 9, 1989 | Substantially Equivalent |
| K890426 | CONSUMMATE AIR THERAPY BED | Apr 5, 1989 | Substantially Equivalent |
| K874801 | ORTHODERM THERAPY BED | Feb 5, 1988 | Substantially Equivalent |
| K871742 | MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER | Jun 15, 1987 | Substantially Equivalent |
| K870514 | THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER | Mar 31, 1987 | Substantially Equivalent |
| K864719 | PFLEX EM(TM) (EXERCISE MONITOR) | Mar 16, 1987 | Substantially Equivalent |