510(k) K921624
- Device
- DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS
- Applicant
- INTERTECH RESOURCES, INC.
- 510(k) number
- K921624
- Product code
- BYH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-06-30
- Date received
- 1992-04-06
- Regulation
- 868.5995
- Classification name
- Drain, Tee (water Trap)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALYCE P MARSHALL
- Address
- 5100 Tice St. Fort Myers FL US 33905 33905
FDA Registration Numbers#
- 3010272829
- 3008867836
- 2518436
- 9611500
- 3001313714
- 3006534321
- 3011987967
- 3014228009
- 3006636961
- 3029706818
- 3006563173
- 1836161
- 3007127332
- 3023272766
- 8010042
- 3007307487
- 3012316249
- 9680235
- 8043316
- 3006783791
- 3004748541
- 3010594263
- 3016734145
- 3013783488
- 3021039857
- 2028807
- 3010034780
- 3021244152
- 3033536319
- 3005587132
- 2518422
- 3009077524
- 9616445
- 2085602
- 3010223399
- 1417592
- 3031887985
- 9710567
- 3003799815
- 3006446479
- 3010834934
- 3003862188
- 3020777588
- 3008806809
- 9611451
- 3006061749
- 8030673
- 8044004
- 3018783526
- 9616354
- 3013426279
- 3003678543
- 3000126629
- 3020460367
- 3003902679
- 3002807267
- 1924066
- 8021995
- 3008115001
- 1314417
- 1526534
- 3031369651
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BYH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K946057 | AQUALARM MOISTURE SENSOR MODEL P85000 | Pegasus Research Corp. | 1995-05-05 |
| K932722 | CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM | Carie Med-Tech Services, Inc. | 1993-08-06 |
| K900047 | THAYER SUCTION EVACUATION CONDENSATE COLLECTION | Thayer Medical Corp. | 1990-04-23 |
| K897057 | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM | Thayer Medical Corp. | 1990-03-16 |
| K900591 | VENT-TRAP CAT# WR1000 | Ventlab Corp. | 1990-03-09 |
| K895479 | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM | Thayer Medical Corp. | 1990-03-09 |
| K885088 | THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM | Thayer Medical Corp. | 1989-01-12 |
| K882739 | INTERTECH LARGE VOLUME WATER TRAP (LVW) | Intertech Resources, Inc. | 1988-08-09 |
| K881790 | SAFETY DRAIN | Ballard Medical Products | 1988-06-21 |
| K873447 | DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR | Dhd Medical Products Div. Diemolding Corp. | 1987-10-30 |
| K864147 | AQUAVALVE | Respiratory Care, Inc. | 1986-12-05 |
| K860884 | SELF-SEALING WATER TRAP/ACCESSORIES | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| K860883 | SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITS | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| K853665 | SPLASH ADAPTOR | Ohio Medical Research, Inc. | 1985-10-10 |
| K834573 | AQUA TRAP | Airlife, Inc. | 1984-03-05 |
Legacy Summary#
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FDA Review#
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