The following data is part of a premarket notification filed by Lifeguard Medical Products, Inc. with the FDA for Regulator Oxygen Mechanical.
| Device ID | K863711 |
| 510k Number | K863711 |
| Device Name: | REGULATOR OXYGEN MECHANICAL |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | LIFEGUARD MEDICAL PRODUCTS, INC. 7476 SHADELAND STATION WAY Indianapolis, IN 46256 |
| Contact | Betty Bruner |
| Correspondent | Betty Bruner LIFEGUARD MEDICAL PRODUCTS, INC. 7476 SHADELAND STATION WAY Indianapolis, IN 46256 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1987-01-27 |