510(k) K954194
- Device
- Disposable Hme/filter
- Applicant
- ENGSTROM MEDICAL
- 510(k) number
- K954194
- Product code
- BYD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-10-20
- Date received
- 1995-09-06
- Regulation
- 868.5375
- Classification name
- Condenser, Heat And Moisture (Artificial Nose)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL E DRYDEN
- Address
- 67920 Klinger Lake Rd. Sturgis MI US 49091 49091
FDA Registration Numbers#
- 9680661
- 3003898360
- 3011987967
- 8010042
- 3010187802
- 8010485
- 3009887154
- 3013576541
- 3009747810
- 3016458361
- 3010957755
- 3031233007
- 1423662
- 2024841
- 3014747754
- 3012521761
- 2025182
- 3011503227
- 3014054118
- 3005587132
- 2031897
- 3010834934
- 9617604
- 3020777588
- 2529776
- 3002907620
- 3018094310
- 3010889742
- 8030673
- 9616445
- 3009171251
- 1928237
- 8021995
- 1824226
- 3004030908
- 9611500
- 3001313714
- 9710644
- 3013188547
- 3010220595
- 1832562
- 3021039857
- 3021244152
- 3008770104
- 9617616
- 3010402691
- 2183585
- 3016634999
- 3010321647
- 3012453745
- 3006446479
- 3022568093
- 3003862188
- 3012262567
- 3008806809
- 3004530184
- 3008278458
- 3008567544
- 2936999
- 3004116032
- 3043226252
- 3005012805
- 3004050971
- 3004365956
- 3005855942
- 3001104093
- 3003902312
- 3043619925
- 3005515211
- 3017937889
- 3004905643
- 3037918935
- 3010838917
- 3016904853
- 3007648359
- 3006783791
- 8043316
- 3010877292
- 3004428458
Source Documents#
Other 510(k) Records For Product Code BYD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955008 | HEAT & MOISTURE EXCHANGER | Intertech Resources, Inc. | 1996-01-30 |
| K953580 | HEAT MOISTURE EXCHANGER | Intertech Resources, Inc. | 1995-09-15 |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | Icor AB | 1995-09-07 |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 |
| K953619 | WARM N WET HME W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Gibeck, Inc. | 1995-08-25 |
| K953540 | EEE | Edentec Corp. | 1995-08-25 |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | Gibeck, Inc. | 1995-08-25 |
| K952845 | HUMID-VENT TRACH-VENT | Gibeck, Inc. | 1995-07-25 |
| K952750 | HUMID-VENT 1 | Gibeck, Inc. | 1995-07-20 |
| K952844 | HUMID-VENT 2 | Gibeck, Inc. | 1995-07-20 |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | Icor AB | 1995-07-13 |
| K952084 | HUMID-VENT FILTER PEDI | Gibeck, Inc. | 1995-06-12 |
| K946209 | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | Med-Plastics Intl., Inc. | 1995-06-08 |
| K952036 | FLEXLIFE | Mallinckrodt Medical | 1995-06-08 |