The following data is part of a premarket notification filed by Intertech/ohio with the FDA for Patient Gas Sampling Kit/5stand Alone Versions.
| Device ID | K863033 |
| 510k Number | K863033 |
| Device Name: | PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Contact | J. E Blake |
| Correspondent | J. E Blake INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-11 |
| Decision Date | 1986-08-20 |