Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
510(k) Number |
K954492 |
Device Name |
MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX |
Applicant |
MERCURY MEDICAL |
11300-A 49TH ST. NORTH |
CLEARWATER,
FL
34622 -4800
|
|
Applicant Contact |
KATHY L HANN |
Correspondent |
MERCURY MEDICAL |
11300-A 49TH ST. NORTH |
CLEARWATER,
FL
34622 -4800
|
|
Correspondent Contact |
KATHY L HANN |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 09/27/1995 |
Decision Date | 10/21/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|