Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K072982 |
Device Name |
PARI HYDRATE V |
Applicant |
PARI INNOVATIVE MANUFACTURERS, INC. |
2943 OAKLAKE BLVD. |
MIDLOTHIAN,
VA
23112
|
|
Applicant Contact |
MIKE JUDGE |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 10/23/2007 |
Decision Date | 11/29/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|