| Device Classification Name |
Calculator, Pulmonary Function Interpretor (Diagnostic)
|
| 510(k) Number |
K880550 |
| Device Name |
BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS |
| Applicant |
| Medimicro Systems, Inc. |
| 3107 N. Jackson Ave. |
|
Tucson,
AZ
85719
|
|
| Applicant Contact |
RONALD C SLATIN |
| Correspondent |
| Medimicro Systems, Inc. |
| 3107 N. Jackson Ave. |
|
Tucson,
AZ
85719
|
|
| Correspondent Contact |
RONALD C SLATIN |
| Regulation Number | 868.1900 |
| Classification Product Code |
|
| Date Received | 02/09/1988 |
| Decision Date | 07/25/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|