The following data is part of a premarket notification filed by Medical Science Products, Inc. with the FDA for 'apnea-electrode'.
| Device ID | K900826 |
| 510k Number | K900826 |
| Device Name: | 'APNEA-ELECTRODE' |
| Classification | Monitor, Breathing Frequency |
| Applicant | MEDICAL SCIENCE PRODUCTS, INC. P.0.BOX 381 Canal Fulton, OH 44614 |
| Contact | Gary Smith |
| Correspondent | Gary Smith MEDICAL SCIENCE PRODUCTS, INC. P.0.BOX 381 Canal Fulton, OH 44614 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-21 |
| Decision Date | 1990-04-26 |