Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K993269 |
Device Name |
IQ NASAL MASK, MODEL P/N 50160 |
Applicant |
SLEEPNET CORPORATION |
1050 PERIMETER RD., |
LOCKHEED AIR CENTER |
MANCHESTER,
NH
03103
|
|
Applicant Contact |
PAUL R CHIESA |
Correspondent |
SLEEPNET CORPORATION |
1050 PERIMETER RD., |
LOCKHEED AIR CENTER |
MANCHESTER,
NH
03103
|
|
Correspondent Contact |
PAUL R CHIESA |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 09/30/1999 |
Decision Date | 10/27/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|