Device Classification Name |
heater, breathing system w/wo controller (not humidifier or nebulizer
|
510(k) Number |
K894936 |
Device Name |
PROTOLOGIC MODEL SER-1 |
Applicant |
PROTOLOGIC, INC. |
RFD 5 BOX 194 |
CORNHILL AT DEARMEADOW |
WEBSTER,
NH
03303
|
|
Applicant Contact |
STEPHEN MACGREGOR |
Correspondent |
PROTOLOGIC, INC. |
RFD 5 BOX 194 |
CORNHILL AT DEARMEADOW |
WEBSTER,
NH
03303
|
|
Correspondent Contact |
STEPHEN MACGREGOR |
Regulation Number | 868.5270
|
Classification Product Code |
|
Date Received | 08/03/1989 |
Decision Date | 01/22/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|