The following data is part of a premarket notification filed by Smith-taylor Mfg. Co., Div. Allied Medical Corp. with the FDA for Econol (portable) Econo 30 & 40 Liter Base Unit.
Device ID | K864280 |
510k Number | K864280 |
Device Name: | ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | SMITH-TAYLOR MFG. CO., DIV. ALLIED MEDICAL CORP. 3079 MARINER WAY Lantana, FL 33462 |
Contact | David Smith |
Correspondent | David Smith SMITH-TAYLOR MFG. CO., DIV. ALLIED MEDICAL CORP. 3079 MARINER WAY Lantana, FL 33462 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-30 |
Decision Date | 1987-01-28 |