The following data is part of a premarket notification filed by Lindley Resuscitator, Inc. with the FDA for Lindley Ii Resuscitator.
| Device ID | K881689 |
| 510k Number | K881689 |
| Device Name: | LINDLEY II RESUSCITATOR |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | LINDLEY RESUSCITATOR, INC. 2216 14TH ST. Meridian, MS 39301 |
| Contact | Lindley, Md |
| Correspondent | Lindley, Md LINDLEY RESUSCITATOR, INC. 2216 14TH ST. Meridian, MS 39301 |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1988-07-08 |