The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Infant/pediatric Resuscitation Circuit W/apl.
Device ID | K911465 |
510k Number | K911465 |
Device Name: | INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Contact | Alberto Velez |
Correspondent | Alberto Velez VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-03 |
Decision Date | 1991-10-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30889483586369 | K911465 | 000 |
30889483586352 | K911465 | 000 |
30889483586338 | K911465 | 000 |
30889483586321 | K911465 | 000 |
30889483586314 | K911465 | 000 |
30889483586291 | K911465 | 000 |
30889483586277 | K911465 | 000 |
30889483586260 | K911465 | 000 |
30889483586246 | K911465 | 000 |
30889483586239 | K911465 | 000 |
30889483585898 | K911465 | 000 |
30889483585881 | K911465 | 000 |
30889483586376 | K911465 | 000 |
30889483586413 | K911465 | 000 |
30889483586437 | K911465 | 000 |
30889483585874 | K911465 | 000 |
30889483585867 | K911465 | 000 |
30889483585843 | K911465 | 000 |
30889483585836 | K911465 | 000 |
30889483585829 | K911465 | 000 |
30889483585812 | K911465 | 000 |
30889483586512 | K911465 | 000 |
30889483586505 | K911465 | 000 |
30889483586475 | K911465 | 000 |
30889483586451 | K911465 | 000 |
30889483586444 | K911465 | 000 |
30889483586406 | K911465 | 000 |