FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
K Number: K954492
·
Decision Oct 21, 1996
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
15
Review Days
390
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Basic Information
- Device Name
- MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
- K Number
- K954492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mercury Medical
- Date Received
- September 27, 1995
- Decision Date
- October 21, 1996
- Product Code
- BWF
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
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