Physician Engineered Products, Inc.
Fryeburg, ME, US
Physician Engineered Products, Inc. appears in FDA device records in Fryeburg, ME. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Physician Engineered Products, Inc. between 1985 and 2012. The busiest year on record is 1988, with 3. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1987 | 1 |
| 1988 | 3 |
| 1998 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110550 | BRIGHT EMBRACE MODEL SBL60 | LBI | Substantially Equivalent | |
| K093618 | BILI-MIRROR MODEL BLM-1 | LBI | Substantially Equivalent | |
| K974830 | ULTRA BILI LIGHT | LBI | Substantially Equivalent | |
| K883818 | MODIFIED REFLUX REDUCER | FMS | Substantially Equivalent | |
| K882291 | RETROFIT BABY FACE SHIELD (RFS) | LBI | Substantially Equivalent | |
| K882278 | RESUSCITATION BAG CONTROLLER (RBC) | BTM | Substantially Equivalent | |
| K873700 | INSTITUTIONAL BILI LIGHT (IBL) | LBI | Substantially Equivalent | |
| K850599 | HOME BILI LIGHTS-MODEL 100 | LBI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2486-2015 | Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60 | Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain