The following data is part of a premarket notification filed by R2 Corp. with the FDA for R2 Paddle Type Cable-adaptor #s 170,171.
Device ID | K800936 |
510k Number | K800936 |
Device Name: | R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | R2 CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-21 |
Decision Date | 1980-05-23 |