The following data is part of a premarket notification filed by Technical Medical Products, Inc. with the FDA for Tech Med Nitrous Oxide Sedation Nasal Inhaler Cir..
| Device ID | K884167 |
| 510k Number | K884167 |
| Device Name: | TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. |
| Classification | Apparatus, Gas-scavenging |
| Applicant | TECHNICAL MEDICAL PRODUCTS, INC. 8932 NORTH SECOND ST. Phoenix, AZ 85020 |
| Contact | James R Moore |
| Correspondent | James R Moore TECHNICAL MEDICAL PRODUCTS, INC. 8932 NORTH SECOND ST. Phoenix, AZ 85020 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-04 |
| Decision Date | 1988-10-28 |