The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for El2-series Blood Collection Reervoir.
Device ID | K930154 |
510k Number | K930154 |
Device Name: | EL2-SERIES BLOOD COLLECTION REERVOIR |
Classification | Reservoir, Blood, Cardiopulmonary Bypass |
Applicant | ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
Contact | Harold W Bryan |
Correspondent | Harold W Bryan ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
Product Code | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-13 |
Decision Date | 1993-07-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20613994842910 | K930154 | 000 |
20613994842903 | K930154 | 000 |