| Device Classification Name |
monitor, oxygen, cutaneous, for infant not under gas anesthesia
|
|---|
| 510(k) Number |
K003943 |
|---|
| 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 |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 12/21/2000 |
|---|
| Decision Date | 05/04/2001 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Anesthesiology
|
|---|
| 510k Review Panel |
Anesthesiology
|
|---|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|