The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Lsp Demand Inhalator Valve Model Spoo68 W/mask.
| Device ID | K884543 |
| 510k Number | K884543 |
| Device Name: | LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK |
| Classification | Valve, Non-rebreathing |
| Applicant | SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
| Contact | Sandra L Davis |
| Correspondent | Sandra L Davis SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-31 |
| Decision Date | 1988-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00899660002888 | K884543 | 000 |
| 00899660002871 | K884543 | 000 |