The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Patient Gas Sampling Line For Ohmeda 6000.
| Device ID | K910509 |
| 510k Number | K910509 |
| Device Name: | PATIENT GAS SAMPLING LINE FOR OHMEDA 6000 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | Rogers |
| Correspondent | Rogers INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688416753 | K910509 | 000 |
| 30351688415510 | K910509 | 000 |
| 35019517236679 | K910509 | 000 |