| Device Classification Name |
Gas, Calibration (Specified Concentration)
|
| 510(k) Number |
K932520 |
| Device Name |
CALIBRATION GAS |
| Applicant |
| Cryodyne Technologies, Inc. |
| 67 Winthrop Rd. |
|
Chester,
CT
06412
|
|
| Applicant Contact |
VINCENT J TOILO |
| Correspondent |
| Cryodyne Technologies, Inc. |
| 67 Winthrop Rd. |
|
Chester,
CT
06412
|
|
| Correspondent Contact |
VINCENT J TOILO |
| Regulation Number | 868.6400 |
| Classification Product Code |
|
| Date Received | 05/25/1993 |
| Decision Date | 08/19/1993 |
| 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
|
|
|