Device Classification Name |
monitor, oxygen, cutaneous, for infant not under gas anesthesia
|
510(k) Number |
K991644 |
Device Name |
MICROGAS 7650 TRANSCUTANEOUS MONITOR |
Applicant |
LINDE MEDICAL SENSORS AG |
AUSTRASSE 25 |
BASEL,
CH
4051
|
|
Applicant Contact |
JEAN-PIERRE PALMA |
Correspondent |
LINDE MEDICAL SENSORS AG |
AUSTRASSE 25 |
BASEL,
CH
4051
|
|
Correspondent Contact |
JEAN-PIERRE PALMA |
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 05/13/1999 |
Decision Date | 05/21/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|