The following data is part of a premarket notification filed by Intertech/ohio with the FDA for Intertech Metered Dose Elbow.
| Device ID | K895144 |
| 510k Number | K895144 |
| Device Name: | INTERTECH METERED DOSE ELBOW |
| Classification | Connector, Airway (extension) |
| Applicant | INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Contact | James Pope |
| Correspondent | James Pope INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-18 |
| Decision Date | 1989-10-19 |