The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Recomed Blood-flow Meter H236-052-02.
Device ID | K840522 |
510k Number | K840522 |
Device Name: | RECOMED BLOOD-FLOW METER H236-052-02 |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | LITTON MEDICAL ELECTRONICS 777 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
Contact | Robert L Casarsa |
Correspondent | Robert L Casarsa LITTON MEDICAL ELECTRONICS 777 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
Product Code | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-07 |
Decision Date | 1985-05-16 |