The following data is part of a premarket notification filed by National Medical Sales, Inc. with the FDA for Model 295 Electronic Respirometer.
| Device ID | K903674 |
| 510k Number | K903674 |
| Device Name: | MODEL 295 ELECTRONIC RESPIROMETER |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | NATIONAL MEDICAL SALES, INC. 26086 GETTY Laguna Niquel, CA 92677 |
| Contact | William D Burch |
| Correspondent | William D Burch NATIONAL MEDICAL SALES, INC. 26086 GETTY Laguna Niquel, CA 92677 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-13 |
| Decision Date | 1991-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B005003030 | K903674 | 000 |
| B005002990 | K903674 | 000 |
| B005002980 | K903674 | 000 |
| B005002960 | K903674 | 000 |
| B005002950 | K903674 | 000 |
| B005002940 | K903674 | 000 |
| B005001930 | K903674 | 000 |