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 |