The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Pm 1800 Conserving Device.
Device ID | K001412 |
510k Number | K001412 |
Device Name: | PM 1800 CONSERVING DEVICE |
Classification | Conserver, Oxygen |
Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | Conley Wallace |
Correspondent | Conley Wallace PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-04 |
Decision Date | 2001-03-20 |