The following data is part of a premarket notification filed by Graseby Medical Ltd. with the FDA for 9000 Infusion Pump.
Device ID | K944721 |
510k Number | K944721 |
Device Name: | 9000 INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | GRASEBY MEDICAL LTD. COLONIAL WAY Watford, Herts., GB Wd24 4lg |
Contact | J Weyman |
Correspondent | J Weyman GRASEBY MEDICAL LTD. COLONIAL WAY Watford, Herts., GB Wd24 4lg |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-23 |
Decision Date | 1995-08-11 |