The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for First Medic Model 510.
Device ID | K896903 |
510k Number | K896903 |
Device Name: | FIRST MEDIC MODEL 510 |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Contact | Raymond W Gifford |
Correspondent | Raymond W Gifford SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Product Code | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-08 |
Decision Date | 1990-12-27 |