Device Classification Name |
Laryngoscope, Non-Rigid
|
510(k) Number |
K951194 |
Device Name |
FI-10M |
Applicant |
PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. |
MIRAMAR,
FL
33025
|
|
Applicant Contact |
PAUL SILVA |
Correspondent |
PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. |
MIRAMAR,
FL
33025
|
|
Correspondent Contact |
PAUL SILVA |
Regulation Number | 868.5530
|
Classification Product Code |
|
Date Received | 03/16/1995 |
Decision Date | 04/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|