510(k) K935441
- Device
- INFINITECH BREATH EZ
- Applicant
- Infinitech, Inc.
- 510(k) number
- K935441
- Product code
- BWN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-07
- Date received
- 1993-11-12
- Regulation
- 878.4950
- Classification name
- Table And Attachments, Operating-Room
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- ALAN T BECKMAN
- Address
- 500 S. Ewing St. Louis MO US 63103 63103
FDA Registration Numbers#
- 3037012186
- 1053198
- 2182318
- 1423537
- 3031582440
- 3011910987
- 8010379
- 3024890239
- 9610612
- 3019502344
- 3014739961
- 3014334038
- 9611579
- 3013404959
- 3015974593
- 3011215096
- 3004967902
- 3013700547
- 3005809810
- 3016851379
- 3007123908
- 3019269298
- 3008627763
- 3014004349
- 9613910
- 3011647337
- 9616088
- 3020767943
- 3010331645
- 3012883081
- 3010699203
- 3005083075
- 3006098219
- 3004608878
- 3015528095
- 3016590299
- 8010273
- 9680168
- 3020188747
- 9611102
- 1818910
- 1218386
- 3027339877
- 3015231789
- 3006467297
- 3017911818
- 9611112
- 2031963
- 3014908171
- 3010610979
- 8010652
- 3010405322
- 3012619193
- 3011659880
- 3004111573
- 3007836437
- 2424366
- 1825034
- 3021284581
- 3014680784
- 3011092264
- 3011230048
- 1063382
- 3015539532
- 3005748481
- 3019856155
- 2030380
- 3013685983
- 3021226419
- 3030192580
- 1061124
- 3043654660
- 3021393544
- 3030441550
- 1220246
- 3029970239
- 9612354
- 3016678414
- 8021896
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BWN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942699 | AIRFRAME SURGICAL DRAPE SUPPORT | Alpha Surgical, Inc. | 1994-07-13 |
| K925005 | ISI SELF-SUPPORTING ARM | Instrumentation Specialties, Inc. | 1993-04-29 |
| K922288 | HOLDER, PEDIATRIC POSITION | Yamashita and Hemsley Business Trust | 1993-02-10 |
| K910783 | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M | Smith & Nephew Equipment Group | 1991-04-02 |
| K902865 | BAUMER SURGICAL TABLE | Sds Dental, Inc. | 1990-09-10 |
| K884558 | IOP ADJUSTABLE STIRRUP | Mend Technologies, Inc. | 1988-11-17 |
| K875291 | SPINAL SURGERY FRAME | T. Korossurgical Instruments Corp. | 1988-01-22 |
| K873272 | ENDOSCOPY TABLE 1532 ENDOSTAR | Stierlen-Maquet AG | 1987-09-08 |
| K860177 | ALLEN UNIVERSAL STIRRUP | Edgewater Medical Equipment Systems | 1986-02-11 |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | Scholten Surgical Instruments, Inc. | 1985-07-02 |
| K843121 | GUIDE TO THE KNEE | Dyonics, Inc. | 1984-09-07 |
| K832340 | OPERATING ROOM TABLES HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | 1983-08-12 |
| K823772 | AMSCO ORTHOGRAPHIC 2 TABLE | American Sterilizer Co. | 1983-01-14 |
| K820574 | ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL | David Simmonds Co., Inc. | 1982-03-23 |
| K812396 | ARTHRO-PREP REST | Northwest Surgical Concepts, Inc. | 1981-11-20 |