The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Criterion Ii & Iia Oxygen Concentrators.
| Device ID | K871603 |
| 510k Number | K871603 |
| Device Name: | CRITERION II & IIA OXYGEN CONCENTRATORS |
| Classification | Generator, Oxygen, Portable |
| Applicant | TIMETER INSTRUMENT CORP. 2501 OREGON PIKE Lancaster, PA 17601 |
| Contact | Robert A Fritz |
| Correspondent | Robert A Fritz TIMETER INSTRUMENT CORP. 2501 OREGON PIKE Lancaster, PA 17601 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-24 |
| Decision Date | 1987-08-13 |