Panels › General Hospital › Product code LBI · Class 2
Unit, Neonatal Phototherapy
Regulation 880.5700
1510(k)s in 12 months (71 all time)
0recalls in 12 months (14 all time)
12recalls that name a 510(k)
Top companies in LBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Natus Medical Incorporated | 6 | 8 |
| Physician Engineered Products, Inc. | 6 | 1 |
| Olympic Medical Corp. | 6 | 0 |
| Ohmeda Medical | 3 | 1 |
| Air-Shields, Inc. | 3 | 0 |
| Draeger Medical Systems, Inc. | 2 | 1 |
| Lumitex, Inc. | 2 | 1 |
| Medix I.C.S.A. | 3 | 0 |
| Atom Medical Corporation | 2 | 0 |
| E & B Technologies, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 16, 1990 | K901987 | OLYMPIC BILI-LITE-PAD(TM) Olympic Medical Corp. | LBI |
| Sep 28, 1989 | K894129 | BILIBLANKET PHOTOTHERAPY DEVICE Ohmeda Medical | LBI |
| Aug 3, 1989 | K892940 | PRECIOUS LITE MODEL 4224 E & B Technologies, Inc. | LBI |
| Mar 8, 1989 | K884133 | PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP Preemicare Corp. | LBI |
| Nov 14, 1988 | K883779 | WALLABY(TM) BLANKET Fiberoptic Medical Products, Inc. | LBI |
| Jun 20, 1988 | K882291 | RETROFIT BABY FACE SHIELD (RFS) Physician Engineered Products, Inc. | LBI |
| Dec 11, 1987 | K873700 | INSTITUTIONAL BILI LIGHT (IBL) Physician Engineered Products, Inc. | LBI |
| Feb 7, 1986 | K854122 | PRECIOUS LITE MODEL 4224 E & B Technologies, Inc. | LBI |
| Jun 17, 1985 | K850599 | HOME BILI LIGHTS-MODEL 100 Physician Engineered Products, Inc. | LBI |
| Apr 5, 1985 | K850181 | AEQUITRON MED-7100 PHOTOTHERAPY LIGHT Aequitron Medical, Inc. | LBI |
| Apr 30, 1984 | K834430 | OMNI INFANT PHOTOTHERAPY UNIT Rocky Mountain Medical Corp. | LBI |
| Apr 20, 1984 | K834335 | AMEDA PHOTOTHERAPY LAMP FOR NEWBORN Egnell, Inc. | LBI |
| Mar 23, 1984 | K840454 | PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO Air-Shields, Inc. | LBI |
| Oct 19, 1983 | K832298 | BABY LIGHT DOSIMETER Rocky Mountain Medical Corp. | LBI |
| Feb 16, 1983 | K830200 | MICROELISA MINIREADER II Dynatech Corp. | LBI |
| Dec 9, 1981 | K813188 | INFANT PHOTOTHERAPY LIGHT Montrose Phototherapy Supply | LBI |
| Apr 23, 1981 | K810953 | MODEL 533 PHOTOTHERAPY UNIT Narco Air-Shields | LBI |
| Dec 10, 1980 | K802702 | NEONATAL PHOTOTHERAPY UNIT Ohio Medical Products | LBI |
| Sep 4, 1979 | K791114 | BILI-DOSIMETER Olympic Medical Corp. | LBI |
| Oct 25, 1977 | K771025 | PHOTOTHERAPY/PROCEDURE LAMP Cavitron Corp. | LBI |
| Nov 2, 1976 | K760872 | PHOTOTHERAPY LIGHT Air-Shields, Inc. | LBI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.