| Device Classification Name |
Apparatus, Gas-Scavenging
|
| 510(k) Number |
K884167 |
| Device Name |
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. |
| Applicant |
| Technical Medical Products, Inc. |
| 8932 N. Second St. |
|
Phoenix,
AZ
85020
|
|
| Applicant Contact |
JAMES R MOORE |
| Correspondent |
| Technical Medical Products, Inc. |
| 8932 N. Second St. |
|
Phoenix,
AZ
85020
|
|
| Correspondent Contact |
JAMES R MOORE |
| Regulation Number | 868.5430 |
| Classification Product Code |
|
| Date Received | 10/04/1988 |
| Decision Date | 10/28/1988 |
| 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
|
|
|